Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/J2top.php on line 78
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry DRAFT GUIDANCE - PharmaFacts
gototopgototop
If you don't find what you're looking for, please let us know.

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry DRAFT GUIDANCE

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process

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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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

page1image8624 page1image8784

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process

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

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

November 2015 OTC

page2image7088

I. II.

A. B. C.

III.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 Advisory Committees and the Nonprescription Drugs Advisory Committee...........................2 Regulation of OTC Sunscreen Products.......................................................................................4 Related Draft Guidance .................................................................................................................5 SECTION 586C(c) OF THE FD&C ACT ...................................................................... 6

IV. PREPARATION AND PUBLIC AVAILABILITY OF INFORMATION GIVEN
TO ADVISORY COMMITTEE MEMBERS ............................................................................ 8

Contains Nonbinding Recommendations

Draft — Not for Implementation

1
2
Sunscreen Innovation Act:
3 Section 586C(c) Advisory Committee Process

41 56 Guidance for Industry

7 8 9

10 11 12 13

14
15
16
I. INTRODUCTION 17

  1. 18  This draft guidance addresses the process by which the Food and Drug Administration (FDA or

  2. 19  Agency) intends to carry out section 586C(c) of the Federal Food, Drug, and Cosmetic Act

  3. 20  (FD&C Act) (21 U.S.C. 360fff-3(c)), as amended by Public Law 113-195 (also referred to as the

  4. 21  Sunscreen Innovation Act (SIA)).2 Under the SIA, the Agency may convene the Advisory

  5. 22  Committee (also referred to in this draft guidance as the Nonprescription Drugs Advisory

  6. 23  Committee or NDAC)3 to provide recommendations on requests submitted to FDA for a

  7. 24  determination of whether a sunscreen active ingredient or combination of sunscreen active

  8. 25  ingredients, for use under specified conditions, is generally recognized as safe and effective

  9. 26  (GRASE) and should be added to the over-the-counter (OTC) sunscreen drug monograph

  10. 27  system. However, section 586C(c) of the FD&C Act provides specific circumstances under

  11. 28  which FDA is not required to convene or submit requests to the NDAC. The SIA also added

  12. 29  section 586D(a)(1) to the FD&C Act (21 U.S.C. 360fff-4(a)(1)), which directs FDA to issue a

  13. 30  draft guidance and a final guidance on the process by which FDA will carry out section 586C(c)

  14. 31  of the FD&C Act, including with respect to how FDA will address the total number of requests

  15. 32  received under section 586A and pending requests, as defined by the SIA.

33

  1. 34  The recommendations in this draft guidance apply to section 586A requests and to pending

  2. 35  requests. A 586A request seeks a determination from FDA on whether a nonprescription

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

    2 21 USC Ch. 9 Sub. 5 Part 1, enacted November 26, 2014.

    3 The SIA defines “Advisory Committee” to mean the Nonprescription Drugs Advisory Committee of the Food and Drug Administration or any successor to such Committee (section 586(1) of the FD&C Act (21 U.S.C. 360fff(1))).

page4image24288

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 listed on the title page.

page4image37344
page4image38920

1

Contains Nonbinding Recommendations

Draft — Not for Implementation

  1. 36  sunscreen active ingredient,4 or a combination of nonprescription sunscreen active ingredients, is

  2. 37  GRASE for use under specified conditions and should be included in the OTC sunscreen drug

  3. 38  monograph (section 586A of the FD&C Act). FD&C Act § 586(6), as amended by the SIA,

  4. 39  defines a “pending request” to mean a request for a nonprescription sunscreen active ingredient

  5. 40  submitted under section 330.14 for consideration for inclusion in the OTC monograph that was

  6. 41  determined to be eligible for review and for which safety and effectiveness data were submitted

  7. 42  prior to the enactment of the SIA. FD&C Act § 586(6) (21 USC § 360fff(6)).5

43

  1. 44  We have published a number of Federal Register notices about rulemaking actions for OTC

  2. 45  sunscreen monograph products and about actions taken under the SIA. Information on these

  3. 46  notices can be found on our “Status of OTC Rulemakings” 6 and “Sunscreen”7 Web sites.

47

  1. 48  In general, FDA’s guidance documents do not establish legally enforceable responsibilities.

  2. 49  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only

  3. 50  as recommendations, unless specific regulatory or statutory requirements are cited. The use of

  4. 51  the word should in Agency guidances means that something is suggested or recommended, but

  5. 52  not required.

53
54
55
II. BACKGROUND
56
57
A. Advisory Committees and the Nonprescription Drugs Advisory Committee 58

  1. 59  FDA has established advisory committees “to secure independent professional expertise in

  2. 60  accomplishing its mission and maintaining the public trust.”8 FDA's advisory committees

  3. 61  provide independent expert advice to the Agency on a range of complex scientific, technical, and

  4. 62  policy issues. An advisory committee meeting also provides a forum for a public hearing on

  5. 63  important matters. Although advisory committees provide important advice and

    4 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))).

    5 These pending requests were submitted as time and extent applications (TEAs) under section 21 CFR 330.14 of FDA’s regulations. 21 CFR 330.14

    6 The “Status of OTC Rulemakings” Web site is available at

    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the- CounterOTCDrugs/StatusofOTCRulemakings/default.htm.

    7 The “Sunscreen” Web site is available at

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

    8 See guidance for industry, Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 (Advisory Committee Guidance), at 1, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm079765.pdf.

page5image26680 page5image26840 page5image27000 page5image27160 page5image27320 page5image27480

2

Contains Nonbinding Recommendations

Draft — Not for Implementation

  1. 64  recommendations to FDA, the Agency has sole discretion concerning action to be taken and

  2. 65  policy to be expressed on any matter considered by an advisory committee.9

66

  1. 67  The NDAC was established under the Federal Advisory Committee Act

  2. 68  statutory and regulatory provisions), which sets forth requirements for the formation and

  3. 69  utilization of advisory committees. 21 CFR part 14 describes the procedures and rules that

  4. 70  govern the Agency’s use of advisory committees (such as the NDAC).

71

  1. 72  The NDAC reviews and evaluates available data concerning the safety and effectiveness of OTC

  2. 73  drug products for use in the treatment of a broad spectrum of human symptoms and diseases and

  3. 74  advises the Agency on the requirements for monographs establishing conditions under which

  4. 75  these drugs are GRASE and not misbranded.11 The NDAC consists of approximately 10 voting

  5. 76  members selected from among specialists knowledgeable in the fields of internal medicine,

  6. 77  family practice, pediatrics, clinical toxicology, clinical pharmacology, pharmacy, and related

  7. 78  specialties.12 The Agency may call upon individuals to supplement the core membership on an

  8. 79  ad hoc basis so that the group considering an issue presented to an advisory committee may also

  9. 80  include members who are specialists with expertise in the particular disease or condition for

  10. 81  which the drug product under consideration is proposed to be indicated.13 For example, NDAC

  11. 82  committees considering matters related to sunscreens may be supplemented with dermatologists.

83

  1. 84  FDA recognizes that advisory committee meetings impose significant resource commitments on

  2. 85  advisory committee members, sponsors, and other public participants, as well as on the Agency

  3. 86  itself, and therefore FDA seeks to limit use of such meetings to important matters. In general,

  4. 87  FDA has discretion to decide whether to present a matter to an advisory committeehere, to the

  5. 88  NDACfor consideration. In making this decision, FDA generally considers several factors,

  6. 89  including the following:

90
91
92
93
94
95
96
97
98

9 Id.
10 Public Law 92-463 (5 U.S.C. Appendix).

11 See the NDAC Charter, available at

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCom mittee/ucm105992.htm.

12 Id.
13 Advisory Committee Guidance, supra note 8, at 2.

(a) (b)

Is the matter at issue of such significant public health importance that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process?

Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process?

10

(in addition to other

page6image28656 page6image28816 page6image28976

3

Contains Nonbinding Recommendations

Draft — Not for Implementation

  1. 99  (c) Is there a special type of expertise that an advisory committee could provide that is

  2. 100  needed for the Agency to fully consider a matter?

101

  1. 102  If one or more of these factors are met, FDA generally refers the matter at issue to an advisory

  2. 103  committee. Conversely, FDA generally refrains from referring a matter to an advisory

  3. 104  committee if none of the factors are met. By prioritizing matters according to these factors, FDA

  4. 105  helps ensure that the finite resources of the advisory committee program are devoted to

  5. 106  consideration of the most important matters, including those matters in which the Agency would

  6. 107  most benefit from the advice of outside experts.

108

  1. 109  Specifically for the NDAC, if FDA determines that it would be useful to convene a meeting to

  2. 110  discuss sunscreen active ingredients being considered through the SIA process, the Agency

  3. 111  would generally make the following preparations, including, but not limited to: (1) identifying

  4. 112  additional members, if necessary, for each NDAC meeting who are specialists on the issue(s) to

  5. 113  be considered, as well as determining their availability; (2) preparing FDA briefing information

  6. 114  and presentations; (3) publishing notice of the NDAC meeting in the Federal Register; and (4)

  7. 115  organizing the logistics of setting up and holding the NDAC meeting. Based on the Agency’s

  8. 116  experience with past NDAC meetings, it may take 4 to 6 months to prepare for an NDAC

  9. 117  meeting.

118
119
B. RegulationofOTCSunscreenProducts
120
121 All sunscreen products are regulated as drugs in the United States under one of two processes: 122
123

124
125

126
127

  1. 128  Products regulated under the new drug approval process may not be marketed without FDA’s

  2. 129  prior review and approval of a new drug application (NDA) or abbreviated new drug application

  3. 130  (ANDA) for each product.14 Products marketed under the OTC drug monograph process are not

  4. 131  individually reviewed and approved prior to marketing. Instead, OTC drug monographs

  5. 132  categorize drugs by therapeutic categories, such as sunscreens. For each category, a monograph

  6. 133  establishes conditions under which any drug that satisfies those conditions and FDA’s general

  7. 134  regulations for OTC drugs is considered to be GRASE and not misbranded when used under the

  8. 135  conditions prescribed, recommended, or suggested in the drug’s labeling.15

136

  1. 137  Only active ingredients that were used in U.S.-marketed sunscreens before the OTC Drug

  2. 138  Review began were eligible to be included in the OTC sunscreen monograph. An active

  3. 139  ingredient or other condition that is ineligible for inclusion in the OTC monograph system is

  4. 140  subject to the new drug approval process.

    14 See sections 505(a) and 301(d) of the FD&C Act. 15 21 CFR Part 330.

The new drug approval process described in 21 CFR part 314

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

page7image30568

4

Contains Nonbinding Recommendations

Draft — Not for Implementation

141

  1. 142  In 2002, before the SIA was enacted, FDA published the “time and extent application” (TEA)

  2. 143  regulation in 21 CFR 330.14. The TEA regulation (§ 330.14(c)) has provided a process through

  3. 144  which any person may request that FDA amend an existing OTC drug monograph to include an

  4. 145  active ingredient or other OTC drug condition, including one not previously marketed in the

  5. 146  United States before the OTC Drug Review began.

147

  1. 148  For OTC sunscreens, the SIA process supplements FDA’s TEA regulation (§ 330.14). The SIA

  2. 149  amended the FD&C Act in part by providing new procedures for establishing that

  3. 150  nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active

  4. 151  ingredients are GRASE and not misbranded when used under the conditions specified in a final

  5. 152  sunscreen order (GRASE determination).16 Active ingredients that are determined to be GRASE

  6. 153  under specified conditions of use in a final sunscreen order may be used in U.S.-marketed

  7. 154  sunscreens without first obtaining an approved NDA or ANDA. Because the monograph and

  8. 155  SIA processes are public, anyone, not just the sponsor who originated the request, may submit

  9. 156  data during public comment periods.

157

  1. 158  As with the TEA process, the SIA process calls for an initial eligibility determination, followed

  2. 159  by submissions of safety and efficacy data, and a GRASE determination phase. However, the

  3. 160  SIA process also requires FDA to make a filing determination17 and to make proposed and final

  4. 161  GRASE determinations in the form of orders rather than the rulemaking required by the TEA

  5. 162  regulation. The SIA process also establishes strict timelines for the necessary administrative

  6. 163  actions. At certain stages in the SIA process, FDA has the discretion to convene the NDAC for

  7. 164  the purpose of reviewing and providing recommendations on a 586A request or on a pending

  8. 165  request.

166
167
C. Related Draft Guidance 168

  1. 169  In addition to this draft guidance, the SIA directs FDA to issue three additional draft guidance

  2. 170  documents on other topics.18 These topics include:

171
172
173
174
175
176
177
178

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

17 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))).

18 Section 586D(a)(1)(A) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)). 5

The format and content of information submitted by a sponsor in support of a 586A request or a pending request;

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

page8image29424

Contains Nonbinding Recommendations

Draft — Not for Implementation

179 The process for withdrawing a 586A request or a pending request. 180

  1. 181  As they become available, FDA will make these draft guidances available on the FDA Drugs

  2. 182  guidance Web page.19

183
184
185
III. SECTION 586C(c) OF THE FD&C ACT 186

  1. 187  Section 586D(a)(1)(A)(iv) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)(iv)) requires FDA to

  2. 188  issue guidance on the process it will use to carry out section 586C(c) of the FD&C Act, including

  3. 189  with respect to how FDA will address the total number of requests received under section 586A

  4. 190  and pending requests.20 Section 586C(c) of the FD&C Act states that:

191
192
193
194
195
196
197
198
199
200

  1. 201  Below, we describe how we intend to carry out section 586C(c), including how we intend to

  2. 202  handle the total number of 586A requests and pending requests.

203

  1. 204  As an initial matter, a sponsor can request that FDA convene the NDAC to consider certain

  2. 205  issues related to the sponsor’s 586A request or pending request. (An NDAC meeting is not

  3. 206  meant to take the place of the public feedback meetings with CDER provided for elsewhere in

  4. 207  the SIA.22) Sponsors of 586A requests and pending requests that are interested in seeking an

  5. 208  NDAC meeting should submit their request for such meeting as early as possible in the process

  6. 209  to provide adequate time for the parties to prepare for the NDAC meeting.

210

  1. 211  The request for an NDAC meeting should be sent as a letter (either by hard copy or

  2. 212  electronically) to the Division of Nonprescription Drug Products (DNDP). If there is an

  3. 213  applicable docket, 23 a duplicate letter should be sent (either by hard copy or electronically) to the

  4. 214  Division of Dockets Management as well. Both addresses are as follows:

    19 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.

    20 Section 586D of the FD&C Act (21 U.S.C. 360fff-4).
    21 Section 586C(c) of the FD&C Act.
    22 See, e.g., section 586B(b)(3)(A), 586C(a)(4), and 586C(b)(7) of the FD&C Act (21 U.S.C. 360fff-2, 360fff-3). 23 If no docket has been opened for the matter, the request should be sent only to the DNDP.

FDA is not required to convene the NDAC “more than once with respect to any request under section 586A or any pending request.”

FDA is not required to convene the NDAC “more than twice in any calendar year with respect to the review under this section.”

FDA is not required to “submit more than a total of 3 requests under section 586A or pending requests to the Advisory Committee per meeting.”21

page9image28888 page9image29048

6

Contains Nonbinding Recommendations

Draft — Not for Implementation

215

  1. 216  Food and Drug Administration

  2. 217  Division of Nonprescription Drug Products

  3. 218  Bldg. 22, Mail Stop 5411

  4. 219  10903 New Hampshire Avenue

  5. 220  Silver Spring, MD 20993

221

  1. 222  Food and Drug Administration

  2. 223  Division of Dockets Management (HFA-305)

  3. 224  5630 Fishers Lane, Rm. 1061

  4. 225  Rockville, MD 20852

  5. 226  Electronic letters should be submitted at http://www.regulations.gov in the applicable

  6. 227  docket.

228

  1. 229  We recommend the sponsor submit the following information as part of a request for an NDAC

  2. 230  meeting:

231
232 1. 233
234
235 2. 236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256 3. 257
258

page10image12632

The subject line should be prominently labeled: “SIA (586A Request/Pending Request) - Request that FDA Convene the Nonprescription Drugs Advisory Committee.”

The body of the letter should contain the following:

-

-

- - -

-

A statement that the sponsor requests FDA to convene the NDAC for review and recommendations regarding a 586A request or a pending request for a sunscreen active ingredient or combination of sunscreen active ingredients under specified conditions of use.

Information about the specific sunscreen active ingredient or combination of sunscreen active ingredients and specified conditions of use to be the subject of the requested NDAC meeting.

The name of the specific sponsor that will present information to the NDAC.
A statement of the specific matter proposed for discussion at the NDAC meeting.

A statement explaining why the specific matter warrants NDAC discussion and why it should be considered at the particular time of the request.

As applicable, the statement should refer to the factors discussed above in Section II.A in support of the request for an NDAC meeting.

The name, title, address, telephone number, and e-mail address of the sponsor’s contact person should be included.

7

 

Contains Nonbinding Recommendations

Draft — Not for Implementation

  1. 259  Upon receipt of the NDAC request,24 DNDP intends to review the letter. FDA intends to

  2. 260  consider an NDAC request to have been made when the Agency acknowledges receipt of the

  3. 261  request letter. DNDP intends to provide an acknowledgment letter to the sponsor within 30 days

  4. 262  of receipt. Acknowledgment of the receipt of the request does not constitute an agreement by

  5. 263  FDA to convene the NDAC. If FDA decides that the NDAC will be convened, FDA will notify

  6. 264  the sponsor.

265

  1. 266  Under the SIA, FDA may decide whether to convene an NDAC for any particular 586A request

  2. 267  or pending request regardless of whether the sponsor has made an NDAC request. FDA intends

  3. 268  to address and prioritize the total number of 586A requests and pending requests received by

  4. 269  using the factors described in Section II.A above to determine whether and when to refer such a

  5. 270  request to the NDAC. For example, FDA would be more likely to convene a meeting for matters

  6. 271  that are dissimilar to those discussed at a previous NDAC and for which a clear path forward had

  7. 272  not already been determined. In addition, FDA may convene an NDAC on its own initiative,

  8. 273  using similar criteria as those factors used to determine whether to present sponsor requests to an

  9. 274  NDAC.

275

  1. 276  As explained above, referring a matter to the NDAC involves a substantial expenditure of the

  2. 277  Agency’s limited resources and time. Accordingly, depending on the total number of 586A

  3. 278  requests and pending requests to be considered by the NDAC, FDA intends to limit the number

  4. 279  of NDAC meetings per year and the number of requests to be considered per meeting as

  5. 280  discussed in section 586C(c) of the FD&C Act.

281

282

  1. 283 IV. PREPARATION AND PUBLIC AVAILABILITY OF INFORMATION GIVEN TO

  2. 284 ADVISORY COMMITTEE MEMBERS

285

  1. 286  For each advisory committee meeting, the sponsor should provide briefing materials to be

  2. 287  considered by the members of the NDAC. For most meetings, these materials should consist of

  3. 288  the sponsor’s briefing document that addresses the issues to be considered by the NDAC, and the

  4. 289  sponsor’s slides to be presented. The briefing document should include all information relevant

  5. 290  to the matters to be discussed at the NDAC meeting, presented in a concise summary.

  6. 291  Information on briefing materials preparation, timelines and public availability of briefing

  7. 292  material information is included in the guidance for industry Advisory Committee Meetings –

  8. 293 Preparation and Public Availability of Information Given to Advisory Committee Members.25

294 295

24 The official date of receipt of the letter may be assigned by FDA and may not necessarily be the date of mailing or of delivery by a delivery service.

25 See guidance for industry, Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members (Advisory Committee Meetings Guidance), available at, http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-gen/documents/document/ucm125650.pdf.

page11image29560 page11image29720

8