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Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry DRAFT GUIDANCE - PharmaFacts
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Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry DRAFT GUIDANCE

Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact Kristen Hardin at 240-402-4246.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

November 2015 OTC

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Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

November 2015 OTC

I. II.

A. B. C.

III. A.

B.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 Regulation of Sunscreen Products ................................................................................................2 Section 586D(a) Draft Guidance on Withdrawal Process...........................................................4 Related Draft Guidance .................................................................................................................4 GENERAL WITHDRAWAL PROCEDURES.............................................................. 5 Request for Withdrawal ................................................................................................................5 Withdrawal Due to Sponsor’s Failure to Take Action................................................................6

EFFECT OF WITHDRAWAL OF 586A REQUESTS AND PENDING
586A Request — Withdrawal........................................................................................................7

1. Withdrawal Prior to an Eligibility Determination or After a Determination That a
Request Is Ineligible..............................................................................................................................7 2. Withdrawal After an Eligibility Determination but Prior to a Filing Determination ......................8 3. Withdrawal After Filing Determination ...........................................................................................8 4. Withdrawal After a Proposed Sunscreen Order Under Section 586(7)(C)......................................9

Pending Requests — Withdrawal .................................................................................................9 New Requests ................................................................................................................................10

IV.
REQUESTS ................................................................................................................................... 7

A.

B. C.

1 2 3 4

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Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request

51 67 Guidance for Industry

8

 9
10
11
12
13
14
15

16
17
18
I. INTRODUCTION 19

  1. 20  This draft guidance addresses the process for (1) withdrawal of a request submitted under section

  2. 21  586A (586A request)2 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by

  3. 22  Public Law 113-195 (also referred to as the Sunscreen Innovation Act or SIA)3 and (2)

  4. 23  withdrawal of a pending request, as defined under section 586(6) of the FD&C Act.4 When

  5. 24  final, the recommendations in this guidance will apply to 586A requests and pending requests5

  6. 25  that seek a determination from FDA of whether a nonprescription sunscreen active ingredient or

  7. 26  a combination of nonprescription sunscreen active ingredients is generally recognized as safe and

    1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.

    2 A 586A request is a request submitted to FDA for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, is generally recognized as safe and effective (GRASE) and should be included in the sunscreen OTC monograph (section 586A of the FD&C Act (21 U.S.C. 360fff-1)).

    3 21 U.S.C. Ch. 9 Sub. 5 Part 1, enacted November 26, 2014.

    4 Section 586(6) of the FD&C Act defines a pending request to mean a request for a nonprescription sunscreen active ingredient submitted under § 330.14 (21 CFR 330.14) for consideration for inclusion in the OTC monograph that was determined to be eligible for review and for which safety and effectiveness data was submitted prior to the enactment of the SIA (section 586(6) of the FD&C Act (21 U.S.C 360fff(6)). These pending requests were submitted as time and extent applications (TEAs) under § 330.14 of FDA’s regulations.

    5 A sunscreen as defined in the SIA means a drug containing one or more sunscreen active ingredients (section 586(9) of the FD&C Act (21 U.S.C. 360fff(9))) and the term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation (section 586 (10) of the FD&C Act (21 U.S.C. 360fff(10))).

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

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  1. 27  effective (GRASE) for use under specified conditions and should be included in the over-the-

  2. 28  counter (OTC) sunscreen drug monograph.

  3. 29  The SIA, enacted on November 26, 2014, added new section 586D(a)(1) to the FD&C Act,

  4. 30  which directs FDA to issue draft and final guidance on the process by which a request under

  5. 31  section 586A or a pending request is withdrawn.6 This draft guidance is organized as follows:

32 33
34

35 36
37
38

39 40

  1. 41  In general, FDA’s guidance documents do not establish legally enforceable responsibilities.

  2. 42  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only

  3. 43  as recommendations, unless specific regulatory or statutory requirements are cited. The use of

  4. 44  the word should in Agency guidances means that something is suggested or recommended, but

  5. 45  not required.

46
47
48
II. BACKGROUND
49
50
A. Regulation of Sunscreen Products
51
52 All sunscreens are regulated as drugs in the United States under one of two processes: 53
54

55 56

The OTC drug monograph process (also known as the OTC Drug Review) described in part 330 (21 CFR part 330), as supplemented by the SIA

Section II provides background information on the sunscreen OTC monograph process and the new procedures under the SIA (the SIA process) for reviewing 586A requests and pending requests for nonprescription sunscreen active ingredients.7

Section III addresses the general withdrawal process for a 586A request or pending request. At certain stages of the SIA process, the sponsor8 who submitted a 586A request or pending request might seek to have it withdrawn, or the request may be withdrawn due to the sponsor’s failure to act on the request and failure to respond to communications from FDA.

Section IV addresses the effect of this withdrawal process on key phases of the SIA process.

The new drug approval process described in part 314 (21 CFR part 314)

57

  1. 58  Products regulated under the new drug approval process may not be marketed without FDA’s

  2. 59  prior review and approval of a new drug application (NDA) or abbreviated new drug application

6 Section 586D(a)(1) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)).

7 We have previously published Federal Register notices about rulemaking actions for OTC sunscreen monograph products and about actions taken under the SIA. This information can be found on our “Status of OTC Rulemakings” and “Sunscreens” Web sites respectively. See http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the- CounterOTCDrugs/StatusofOTCRulemakings/default.htm and http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the- CounterMedicines/ucm239463.htm.

8 A sponsor under the SIA is a person that has submitted a 586A request, a pending request, or any other application subject to the SIA (section 586(8) of the FD&C Act (21 U.S.C. 360fff(8))).

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  1. 60  (ANDA) for each product.9 Products marketed under the OTC drug monograph process are not

  2. 61  individually reviewed and approved prior to marketing. Instead, OTC drug monographs

  3. 62  categorize drugs by therapeutic categories, such as sunscreens. For each category, a monograph

  4. 63  establishes conditions under which any drug that satisfies those conditions and FDA’s general

  5. 64  regulations for OTC drugs is considered to be GRASE and not misbranded when used under the

  6. 65  conditions prescribed, recommended, or suggested in the drug’s labeling.10

66

  1. 67  Only active ingredients that were used in U.S.-marketed sunscreens before the OTC Drug

  2. 68  Review began were eligible to be included in the OTC sunscreen monograph. An active

  3. 69  ingredient or other condition that is ineligible for inclusion in the OTC monograph system is

  4. 70  subject to the new drug approval process.

71

  1. 72  In 2002, before the SIA was enacted, FDA published the “time and extent application” (TEA)

  2. 73  regulation in 21 CFR 330.14. The TEA regulation (§ 330.14(c)) has provided a process through

  3. 74  which any person may request that FDA amend an existing OTC drug monograph to include an

  4. 75  active ingredient or other OTC drug condition, including one not previously marketed in the

  5. 76  United States before the OTC Drug Review began.

77

  1. 78  For OTC sunscreens, the SIA process supplements FDA’s TEA regulation (§ 330.14). The SIA

  2. 79  amended the FD&C Act in part by providing new procedures for establishing that

  3. 80  nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active

  4. 81  ingredients are GRASE and not misbranded when used under the conditions specified in a final

  5. 82  sunscreen order (GRASE determination).11 Active ingredients that are determined to be GRASE

  6. 83  under specified conditions of use in a final sunscreen order may be used in U.S.-marketed

  7. 84  sunscreens without first obtaining an approved NDA or ANDA. Because the monograph and

  8. 85  SIA processes are public, anyone, not just the sponsor who originated the request, may submit

  9. 86  data during public comment periods.

87

  1. 88  As with the TEA process, the SIA process calls for an initial eligibility determination, followed

  2. 89  by submissions of safety and efficacy data, and a GRASE determination phase. However, the

  3. 90  SIA process also requires FDA to make a filing determination12 and to make proposed and final

  4. 91  GRASE determinations in the form of orders rather than the rulemaking required by the TEA

  5. 92  regulation. The SIA process also establishes strict timelines for the necessary administrative

  6. 93  actions.

94 95 96

9 See sections 505(a) and 301(d) of the FD&C Act.
10 21 CFR part 330.
11 Section 586C of the FD&C Act (21 U.S.C. 360fff-3).

12 The filing determination requires FDA to determine whether the safety and efficacy data submitted to support a GRASE determination are appropriately formatted and sufficiently complete to support a substantive GRASE review (section 586B(b)(2) of the FD&C Act (21 U.S.C. 360fff-2(b)(2))).

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97 B. Section 586D(a) Draft Guidance on Withdrawal Process 98

  1. 99  Section 586D(a)(1)(A)(iii) of the FD&C Act requires the Agency to issue guidance on “the

  2. 100  process by which a request under section 586A or a pending request is withdrawn.”13 The

  3. 101  statute does not address the process by which a sponsor or FDA could withdraw a 586A request

  4. 102  or pending request under the SIA. In addition, FDA’s current regulations governing TEA

  5. 103  requests do not include a withdrawal process (§ 330.14). As directed by the SIA, FDA is issuing

  6. 104  this draft guidance to explain how, at different stages of the SIA process, a 586A request or

  7. 105  pending request may be withdrawn.

106

  1. 107  Although neither the SIA nor the current TEA regulation otherwise discuss the process of

  2. 108  withdrawal, we note, that in the preamble of the final rule promulgating the TEA regulation,

  3. 109  FDA discussed the effect of a withdrawal of a TEA request when a non-GRASE determination

  4. 110  for that condition is expected. We explained that although a sponsor can withdraw its request,

  5. 111  we would still consider the submission to be a part of the public docket and FDA would still

  6. 112  have the discretion to publish the Agency’s non-GRASE decision, notwithstanding the

  7. 113  withdrawal.14 It is the Agency’s view that consideration for OTC drug monograph status is a

  8. 114  public process and all information provided should be part of the public record if the condition is

  9. 115  determined to be eligible.15 Thus, after the data and information has been submitted in response

  10. 116  to a notice of eligibility (NOE), the Agency will have the information upon which to base its

  11. 117  GRASE determination.

118

  1. 119  Based on the requirements of the SIA and the Agency’s prior consideration of a similar issue in

  2. 120  implementing the TEA regulation,16 this draft guidance describes our recommendations for

  3. 121  addressing the process for withdrawal of a 586A request or pending request and the effect of a

  4. 122  withdrawal on the GRASE review process.

123
124
C. Related Draft Guidance 125

  1. 126  In addition to this draft guidance, the SIA directs FDA to issue three additional draft guidance

  2. 127  documents on other topics.17 These topics include:

128
129
The format and content of information submitted by a sponsor in support of a 586A

130 131

request or a pending request;

13 Section 586C(a)(1)(A)(iii) of the FD&C Act (21 U.S.C. 360fff-3(a)(1)(A)(iii)). 14 See 2002 TEA Final Rule, 67 FR 3060 at 3066 and 3067.

15 Id. There may be limited situations in which certain information submitted may be considered confidential. Id.; see also section 586B(a)(3) of the FD&C Act (21 U.S.C. 360fff-4(a)(3)).

16 See 2002 TEA Final Rule, 67 FR 3060 at 3067.
17 Section 586D(a)(1)(A) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)).

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The data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and not misbranded; and

132 133
134
135

136 137
138
139

140 141

  1. 142  As they become available, FDA will make these draft guidances available on the FDA Drugs

  2. 143  guidance Web page.18

144
145
146
III. 147
148
149

  1. 150  A sponsor seeking to withdraw its 586A request or pending request should submit its written or

  2. 151  electronic request for withdrawal to the docket for that proceeding with a copy to the Division of

  3. 152  Nonprescription Drug Products in the Office of Drug Evaluation IV.19 Written requests should

  4. 153  be submitted to:

154

  1. 155  Division of Dockets Management (HFA-305)

  2. 156  Food and Drug Administration

  3. 157  5630 Fishers Lane, Rm. 1061

  4. 158  Rockville, MD 20852

  5. 159  and

  6. 160  Food and Drug Administration

  7. 161  Division of Nonprescription Drug Products

  8. 162  Bldg. 22, Mail Stop 5411

  9. 163  10903 New Hampshire Avenue

  10. 164  Silver Spring, MD 20993

165

  1. 166  Electronic requests, and electronic copies of written requests, should be submitted to

  2. 167 http://www.regulations.gov in the applicable docket. The withdrawal request should include the

  3. 168  following information:

  4. 169 submitter

    18 When available, FDA will post each draft guidance available on the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    When final, the guidance will represent the FDA’s current thinking on this topic.

    19 If the Agency has not opened a docket for the proceeding, the sponsor should submit its written request for withdrawal to the Division of Nonprescription Drug Products in the Office of Drug Evaluation IV as described above.

The process by which FDA will carry out section 586C(c) of the FD&C Act as amended by the SIA, including the process for requesting an advisory committee meeting, the circumstances that limit the number and frequency of advisory committee meetings FDA is required to convene, and the number of requests to be considered per advisory committee meeting.

GENERAL WITHDRAWAL PROCEDURES A. Request for Withdrawal

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  1. 170

  2. 171

  3. 172

173

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submission date
active ingredient or other condition that is the subject of the submission applicable docket number

  1. 174  A request to withdraw informs FDA of the sponsor’s intent to discontinue its request for a

  2. 175  determination from the Agency of whether the sunscreen active ingredient, or combination of

  3. 176  active ingredients, is GRASE and should be included in the sunscreen OTC monograph. FDA

  4. 177  intends to respond to a request for withdrawal from the sponsor by sending a letter to the sponsor

  5. 178  acknowledging the withdrawal of the request. If the withdrawal is made after a docket has been

  6. 179  opened for that proceeding, FDA will place a copy of the acknowledgement letter in that docket.

180

  1. 181  As explained in more detail below, generally, if a sponsor submits a request to withdraw its

  2. 182  586A or pending request at any time prior to FDA’s issuance of a final sunscreen order, FDA

  3. 183  intends to consider the request withdrawn. If a proposed sunscreen order has not been issued,

  4. 184  FDA intends to stop its review of that request. However, similar to FDA’s approach under the

  5. 185  TEA regulation, if a proposed sunscreen order has already been issued prior to the withdrawal,

  6. 186  FDA intends to proceed with issuing a final sunscreen order consistent with the SIA and as

  7. 187  priorities and resources permit. In addition, FDA intends that the original submission and the

  8. 188  data and information submitted in support of the 586A request will remain a part of the public

  9. 189  docket for that proceeding, and FDA may continue to rely on such data and information.20

190
191
192
B. Withdrawal Due to Sponsor’s Failure to Take Action 193

  1. 194  We note that there are several stages in the review process for 586A requests and pending

  2. 195  requests at which the Agency will be waiting for the sponsor or other interested parties to submit

  3. 196  necessary information or data. With the exception of designated comment periods, the SIA does

  4. 197  not require the sponsor or others to submit such information or data within an established

  5. 198  deadline. Based on our past experience with the OTC monograph process, this may create a

  6. 199  situation in which the necessary information or data are never submitted.

200

  1. 201  Accordingly, we recommend that sponsors keep us apprised of the anticipated timing of their

  2. 202  data submissions if those submissions are expected to occur more than 1 year from the date of

  3. 203  the notice of eligibility (NOE) or the sponsor’s most recent submission. To facilitate the review

  4. 204  process and better utilize the Agency’s time and resources, FDA may also request periodic

  5. 205  updates from the sponsor on the status of the information or data to be submitted if nothing has

  6. 206  been submitted by the sponsor for more than 1 year. If an update is not provided or no

  7. 207  information or data are submitted to FDA within 90 days of FDA’s request for an update, the

  8. 208  Agency intends to consider the sponsor’s failure to respond to be a request by the sponsor to

  9. 209  withdraw the 586A or pending request. By failing to take action, the sponsor will have

  10. 210  indicated that it is no longer interested in pursuing a GRASE determination for a particular

  11. 211  request. FDA intends to send a letter notifying the sponsor that the request is withdrawn, and

  12. 212  FDA intends to place a copy of the letter in the public docket for that proceeding. It is the

    20 See 2002 TEA Final Rule, 67 FR 3060 at 3067. Generally, the Agency will open a docket when the notice of eligibility (NOE) is issued.

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  1. 213  Agency’s view that this withdrawal process will provide notice to the public of the status of the

  2. 214  proceeding and of our intent to stop review of the request due to the sponsor’s failure to take

  3. 215  action. As discussed in section IV.C, if a 586A request or pending request is withdrawn, a

  4. 216  sponsor can submit a new request for the same sunscreen active ingredient or combination of

  5. 217  sunscreen active ingredients.

218
219
220
IV. EFFECT OF WITHDRAWAL OF 586A REQUESTS AND PENDING REQUESTS 221

  1. 222  As explained above, the SIA process calls for an initial eligibility determination phase followed

  2. 223  by the submission of safety and efficacy data, a filing determination by FDA, and a GRASE

  3. 224  determination phase, which includes a proposed sunscreen order and final sunscreen order.

225

  1. 226  If a 586A request is determined to be eligible for review, the Agency opens a docket for the

  2. 227  proceeding, publicly posts the NOE and the 586A request,21 and provides interested parties 45

  3. 228  days to submit comments relating to a GRASE determination on the request, including data and

  4. 229  other information related to the safety and efficacy of the request.22

230

  1. 231  A key step in the SIA process requires FDA to determine whether the information and data

  2. 232  submitted to support a GRASE determination are appropriately formatted and sufficiently

  3. 233  complete to support a substantive GRASE review (filing determination).23 Based on that

  4. 234  determination, FDA will either file or refuse to file the request (thus triggering various action

  5. 235  timelines).24

236

  1. 237  The following sections address the effect that a withdrawal of a 586A request or pending request

  2. 238  may have on these and other key phases of the SIA process.

239
240
241
A. 242
243
1. 244
245

  1. 246  If a sponsor withdraws its 586A request before FDA issues an eligibility determination, we

  2. 247  intend to stop our review of the request because we no longer have a 586A request upon which to

  3. 248  make a determination of eligibility. Similarly, if FDA has made a determination that the 586A

  4. 249  request is not eligible for review under the SIA process, the matter may be considered closed

  5. 250  without the need for a withdrawal because there is no longer an open matter from which to

    21 For information on the treatment of confidential data in 586A requests, see section 586B(a)(3) of the FD&C Act (21 U.S.C. 360fff-2(a)(3)).

    22 Section 586B(b)(1) of the FD&C Act (21 U.S.C. 360fff-2(b)(1)). 23 Section 586B(b)(2) of the FD&C Act (21 U.S.C. 360fff-2(b)(2)). 24 Section 586B(b)(3) of the FD&C Act (21 U.S.C. 360fff-2(b)(3)).

586A Request — Withdrawal

Withdrawal Prior to an Eligibility Determination or After a Determination That a Request Is Ineligible

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  1. 251  withdraw. For requests withdrawn prior to an eligibility determination, FDA does not intend to

  2. 252  publicly post the withdrawal notification.

253
254
2. 255
256
257
258

  1. 259  If a sponsor withdraws its 586A request after FDA has determined that the request is eligible for

  2. 260  review and has issued an NOE, but before the data package described in section 586B(b)(1) of

  3. 261  the FD&C Act has been submitted, FDA intends to stop its review of the withdrawn request.

  4. 262  Upon the sponsor’s withdrawal, there will be no 586A request which may be filed. If a new

  5. 263  586A request is submitted for the same sunscreen active ingredient or combination of sunscreen

  6. 264  active ingredients after the withdrawal of the original request, we intend to follow the process for

  7. 265  the new request as explained in section IV.C.

266
267 b. Postsubmission of Data Package 268

  1. 269  If a sponsor withdraws its 586A request after FDA has determined that the request is eligible for

  2. 270  review and has issued an NOE determination, and after the data package described in section

  3. 271  586B(b)(1) of the FD&C Act has been submitted, but prior to FDA’s filing determination, the

  4. 272  Agency intends to stop its review of the 586A request. Upon the sponsor’s withdrawal, there

  5. 273  will be no 586A request. If a new 586A request is submitted for the same sunscreen active

  6. 274  ingredient or combination of sunscreen active ingredients after the withdrawal of the original

  7. 275  request, we intend to follow the process for the new request as explained in section IV.C.

276
277
3. Withdrawal After Filing Determination

Withdrawal After an Eligibility Determination but Prior to a Filing Determination

a. Presubmission of Data Package

278 279 280

  1. 281  If FDA determines that the data and information are sufficiently complete to conduct a GRASE

  2. 282  review, the Agency will file the 586A request. If a sponsor withdraws its 586A request after the

  3. 283  Agency has filed the request and before the Agency has issued the proposed sunscreen order, the

  4. 284  Agency intends to stop its review of the withdrawn request. If a new 586A request is submitted

  5. 285  for the same sunscreen active ingredient or combination of sunscreen active ingredients after the

  6. 286  withdrawal of the original request, we intend to follow the process for the new request as

  7. 287  explained in section IV.C.

288
289 b. Refuse to File 290

  1. 291  If a sponsor withdraws its 586A request after FDA refuses to file the request, the Agency intends

  2. 292  to stop its review of the withdrawn request. A sponsor can submit additional data or other

  3. 293  information in response to a refuse to file. If a sponsor withdraws its 586A request after it has

  4. 294  submitted additional data or information, but before FDA has made a new filing determination,

a. Filed 586A Request

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  1. 295  the Agency intends to stop its review of the withdrawn request.25 If a new 586A request is

  2. 296  submitted for the same sunscreen active ingredient or combination of sunscreen active

  3. 297  ingredients after FDA refuses to file the original 586A request, we intend to follow the process

  4. 298  for the new request as explained in section IV.C.

299
300
4. Withdrawal After a Proposed Sunscreen Order Under Section 586(7)(C) 301

  1. 302  If a sponsor withdraws the 586A request after the Agency has made a tentative determination of

  2. 303  GRASE status of an active ingredient under certain conditions of use in a proposed sunscreen

  3. 304  order, 26 FDA intends to deem the 586A request withdrawn, but may continue to rely on the

  4. 305  information submitted to the docket and may proceed to issuing a final sunscreen order. As

  5. 306  explained in section II.B, we consider all data and information submitted (e.g., in response to the

  6. 307  NOE, a feedback letter, or tentative GRASE determination) to be part of the public record. Upon

  7. 308  submission of such information, the Agency has the data upon which to base its final sunscreen

  8. 309  order notwithstanding the withdrawal. If a new 586A request is submitted for the same

  9. 310  sunscreen active ingredient or combination of sunscreen active ingredients after the withdrawal

  10. 311  of the original request, we intend to follow the process for the new request as explained in

  11. 312  section IV.C.

313
314
315
B. Pending Requests — Withdrawal 316

  1. 317  As explained above, a pending request under the SIA is defined to mean a request for a

  2. 318  nonprescription sunscreen active ingredient submitted under § 330.14 for consideration for

  3. 319  inclusion in the OTC monograph that was determined to be eligible for review and for which

  4. 320  safety and effectiveness data were submitted prior to the enactment of the SIA (section 586(6) of

  5. 321  the FD&C Act). There are eight pending requests as defined under section 586(6) of the FD&C

  6. 322  Act. FDA has issued proposed sunscreen orders for all eight pending requests.27 As of the date

  7. 323  of this draft guidance, all of the proposed sunscreen orders for these pending requests tentatively

  8. 324  determined that the active ingredients are not GRASE and more data are necessary to allow FDA

  9. 325  to determine otherwise. 28

    25 Section 586B(b)(3) of the FD&C Act provides sponsors with a process to submit additional information and request meetings if FDA refuses to file the request. If FDA makes a new filing determination based on the additional information and accepts the request for filing, then any withdrawal of the request sought thereafter will fall under the approach described in section IV.A.3.a.

    26 Section 586C(a)(5)(A) of the FD&C Act (21 U.S.C. 360fff-3(a)(5)(A)). Under the SIA, FDA has 300 days to evaluate the information and data submitted to the docket and to issue a proposed sunscreen order on its GRASE determination (section 586C(a)(1) of the FD&C Act (21 U.S.C. 360fff-3(a)(1))). In the proposed sunscreen order, FDA can find that the active ingredient under consideration is GRASE, not GRASE, or not GRASE and more information and data are necessary to allow FDA to determine otherwise (section 586(7) of the FD&C Act (21 U.S.C. 360fff(7))). The sponsor and interested parties will have 45 days to submit comments on the proposed order (section 586C(a)(3) of the FD&C Act (21 U.S.C. 360fff-3(a)(3))).

    27 Section 586C(b)(3) of the FD&C Act (21 U.S.C. 360fff-3(b)(3)).

    28 http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the- CounterMedicines/ucm239463.htm.

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Contains Nonbinding Recommendations

Draft — Not for Implementation

326

  1. 327  Accordingly, FDA intends for the same withdrawal process described in section IV.A.4 to apply

  2. 328  if a sponsor of a pending request withdraws the pending request prior to the issuance of the final

  3. 329  sunscreen order. If a new 586A request is submitted for the same sunscreen active ingredient

  4. 330  after the withdrawal of the pending request, we intend to follow the process for the new request

  5. 331  as explained in section IV .C.

332 333 334

  1. 335  The same or a different sponsor can submit a new 586A request for the same sunscreen active

  2. 336  ingredient or combination of sunscreen active ingredients after the original request has been

  3. 337  withdrawn. If FDA has already made a determination that the active ingredient is eligible for

  4. 338  further review under the SIA process, FDA intends for the existing NOE to remain in effect and

  5. 339  the sunscreen active ingredient or combination of active ingredients to remain eligible for

  6. 340  consideration under the SIA. The sponsor of the new 586A request may rely on the existing

  7. 341  NOE for that active ingredient; but, thereafter, we intend to treat the new submission as a new

  8. 342  586A request under the SIA process, and the sponsor should submit a new and complete data

  9. 343  submission package for its request. The data package may include data and other information

  10. 344  that were submitted as part of a prior 586A or pending request for that ingredient under the SIA.

  11. 345  If there is no existing NOE or the active ingredient has been found ineligible, then we intend to

  12. 346  treat the submission of another 586A request for this ingredient as a new 586A request subject to

  13. 347  the full SIA process, including an eligibility determination.

348 349

C. New Requests

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