Source: http://www.pharmafacts.com/guidances/fda-guidances/sunscreen-innovation-act-section-586cc-advisory-committee-process-guidance-for-industry-draft-guidance
Timestamp: 2017-08-22 18:36:16
Document Index: 676549615

Matched Legal Cases: ['art 1', '§ 586', '§ 586', '§ 360', 'art 14', 'art 330', 'art 314', '§ 330', '§ 330']

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry DRAFT GUIDANCE - PharmaFacts
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OTC Sunscreen Products.......................................................................................4 Related Draft Guidance .................................................................................................................5 SECTION 586C(c) OF THE FD&C ACT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
2 Sunscreen Innovation Act:
3 Section 586C(c) Advisory Committee Process
41 56 Guidance for Industry
16 I. INTRODUCTION 17
18 This draft guidance addresses the process by which the Food and Drug Administration (FDA or
19 Agency) intends to carry out section 586C(c) of the Federal Food, Drug, and Cosmetic Act
20 (FD&C Act) (21 U.S.C. 360fff-3(c)), as amended by Public Law 113-195 (also referred to as the
21 Sunscreen Innovation Act (SIA)).2 Under the SIA, the Agency may convene the Advisory
22 Committee (also referred to in this draft guidance as the Nonprescription Drugs Advisory
23 Committee or NDAC)3 to provide recommendations on requests submitted to FDA for a
24 determination of whether a sunscreen active ingredient or combination of sunscreen active
25 ingredients, for use under specified conditions, is generally recognized as safe and effective
26 (GRASE) and should be added to the over-the-counter (OTC) sunscreen drug monograph
27 system. However, section 586C(c) of the FD&C Act provides specific circumstances under
28 which FDA is not required to convene or submit requests to the NDAC. The SIA also added
29 section 586D(a)(1) to the FD&C Act (21 U.S.C. 360fff-4(a)(1)), which directs FDA to issue a
30 draft guidance and a final guidance on the process by which FDA will carry out section 586C(c)
31 of the FD&C Act, including with respect to how FDA will address the total number of requests
32 received under section 586A and pending requests, as defined by the SIA.
34 The recommendations in this draft guidance apply to section 586A requests and to pending
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))).
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.
36 sunscreen active ingredient,4 or a combination of nonprescription sunscreen active ingredients, is
37 GRASE for use under specified conditions and should be included in the OTC sunscreen drug
38 monograph (section 586A of the FD&C Act). FD&C Act § 586(6), as amended by the SIA,
39 defines a “pending request” to mean a request for a nonprescription sunscreen active ingredient
40 submitted under section 330.14 for consideration for inclusion in the OTC monograph that was
41 determined to be eligible for review and for which safety and effectiveness data were submitted
42 prior to the enactment of the SIA. FD&C Act § 586(6) (21 USC § 360fff(6)).5
44 We have published a number of Federal Register notices about rulemaking actions for OTC
45 sunscreen monograph products and about actions taken under the SIA. Information on these
46 notices can be found on our “Status of OTC Rulemakings” 6 and “Sunscreen”7 Web sites.
48 In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
49 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
50 as recommendations, unless specific regulatory or statutory requirements are cited. The use of
51 the word should in Agency guidances means that something is suggested or recommended, but
52 not required.
55 II. BACKGROUND
57 A. Advisory Committees and the Nonprescription Drugs Advisory Committee 58
59 FDA has established advisory committees “to secure independent professional expertise in
60 accomplishing its mission and maintaining the public trust.”8 FDA's advisory committees
61 provide independent expert advice to the Agency on a range of complex scientific, technical, and
62 policy issues. An advisory committee meeting also provides a forum for a public hearing on
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.
64 recommendations to FDA, the Agency has sole discretion concerning action to be taken and
65 policy to be expressed on any matter considered by an advisory committee.9
67 The NDAC was established under the Federal Advisory Committee Act
68 statutory and regulatory provisions), which sets forth requirements for the formation and
69 utilization of advisory committees. 21 CFR part 14 describes the procedures and rules that
70 govern the Agency’s use of advisory committees (such as the NDAC).
72 The NDAC reviews and evaluates available data concerning the safety and effectiveness of OTC
73 drug products for use in the treatment of a broad spectrum of human symptoms and diseases and
74 advises the Agency on the requirements for monographs establishing conditions under which
75 these drugs are GRASE and not misbranded.11 The NDAC consists of approximately 10 voting
76 members selected from among specialists knowledgeable in the fields of internal medicine,
77 family practice, pediatrics, clinical toxicology, clinical pharmacology, pharmacy, and related
78 specialties.12 The Agency may call upon individuals to supplement the core membership on an
79 ad hoc basis so that the group considering an issue presented to an advisory committee may also
80 include members who are specialists with expertise in the particular disease or condition for
81 which the drug product under consideration is proposed to be indicated.13 For example, NDAC
82 committees considering matters related to sunscreens may be supplemented with dermatologists.
84 FDA recognizes that advisory committee meetings impose significant resource commitments on
85 advisory committee members, sponsors, and other public participants, as well as on the Agency
86 itself, and therefore FDA seeks to limit use of such meetings to important matters. In general,
87 FDA has discretion to decide whether to present a matter to an advisory committee here, to the
88 NDACfor consideration. In making this decision, FDA generally considers several factors,
89 including the following:
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.
13 Advisory Committee Guidance, supra note 8, at 2.
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?
(in addition to other
99 (c) Is there a special type of expertise that an advisory committee could provide that is
100 needed for the Agency to fully consider a matter?
102 If one or more of these factors are met, FDA generally refers the matter at issue to an advisory
103 committee. Conversely, FDA generally refrains from referring a matter to an advisory
104 committee if none of the factors are met. By prioritizing matters according to these factors, FDA
105 helps ensure that the finite resources of the advisory committee program are devoted to
106 consideration of the most important matters, including those matters in which the Agency would
107 most benefit from the advice of outside experts.
109 Specifically for the NDAC, if FDA determines that it would be useful to convene a meeting to
110 discuss sunscreen active ingredients being considered through the SIA process, the Agency
111 would generally make the following preparations, including, but not limited to: (1) identifying
112 additional members, if necessary, for each NDAC meeting who are specialists on the issue(s) to
113 be considered, as well as determining their availability; (2) preparing FDA briefing information
114 and presentations; (3) publishing notice of the NDAC meeting in the Federal Register; and (4)
115 organizing the logistics of setting up and holding the NDAC meeting. Based on the Agency’s
116 experience with past NDAC meetings, it may take 4 to 6 months to prepare for an NDAC
117 meeting.
119 B. RegulationofOTCSunscreenProducts
121 All sunscreen products are regulated as drugs in the United States under one of two processes: 122
123 
125 
128 Products regulated under the new drug approval process may not be marketed without FDA’s
129 prior review and approval of a new drug application (NDA) or abbreviated new drug application
130 (ANDA) for each product.14 Products marketed under the OTC drug monograph process are not
131 individually reviewed and approved prior to marketing. Instead, OTC drug monographs
132 categorize drugs by therapeutic categories, such as sunscreens. For each category, a monograph
133 establishes conditions under which any drug that satisfies those conditions and FDA’s general
134 regulations for OTC drugs is considered to be GRASE and not misbranded when used under the
135 conditions prescribed, recommended, or suggested in the drug’s labeling.15
137 Only active ingredients that were used in U.S.-marketed sunscreens before the OTC Drug
138 Review began were eligible to be included in the OTC sunscreen monograph. An active
139 ingredient or other condition that is ineligible for inclusion in the OTC monograph system is
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
142 In 2002, before the SIA was enacted, FDA published the “time and extent application” (TEA)
143 regulation in 21 CFR 330.14. The TEA regulation (§ 330.14(c)) has provided a process through
144 which any person may request that FDA amend an existing OTC drug monograph to include an
145 active ingredient or other OTC drug condition, including one not previously marketed in the
146 United States before the OTC Drug Review began.
148 For OTC sunscreens, the SIA process supplements FDA’s TEA regulation (§ 330.14). The SIA
149 amended the FD&C Act in part by providing new procedures for establishing that
150 nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active
151 ingredients are GRASE and not misbranded when used under the conditions specified in a final
152 sunscreen order (GRASE determination).16 Active ingredients that are determined to be GRASE
153 under specified conditions of use in a final sunscreen order may be used in U.S.-marketed
154 sunscreens without first obtaining an approved NDA or ANDA. Because the monograph and
155 SIA processes are public, anyone, not just the sponsor who originated the request, may submit
156 data during public comment periods.
158 As with the TEA process, the SIA process calls for an initial eligibility determination, followed
159 by submissions of safety and efficacy data, and a GRASE determination phase. However, the
160 SIA process also requires FDA to make a filing determination17 and to make proposed and final
161 GRASE determinations in the form of orders rather than the rulemaking required by the TEA
162 regulation. The SIA process also establishes strict timelines for the necessary administrative
163 actions. At certain stages in the SIA process, FDA has the discretion to convene the NDAC for
164 the purpose of reviewing and providing recommendations on a 586A request or on a pending
165 request.
167 C. Related Draft Guidance 168
169 In addition to this draft guidance, the SIA directs FDA to issue three additional draft guidance
170 documents on other topics.18 These topics include:
172 • 173
175 • 176
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
179 • The process for withdrawing a 586A request or a pending request. 180
181 As they become available, FDA will make these draft guidances available on the FDA Drugs
182 guidance Web page.19
185 III. SECTION 586C(c) OF THE FD&C ACT 186
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
188 issue guidance on the process it will use to carry out section 586C(c) of the FD&C Act, including
189 with respect to how FDA will address the total number of requests received under section 586A
190 and pending requests.20 Section 586C(c) of the FD&C Act states that:
192 • 193
195 • 196
198 • 199
201 Below, we describe how we intend to carry out section 586C(c), including how we intend to
202 handle the total number of 586A requests and pending requests.
204 As an initial matter, a sponsor can request that FDA convene the NDAC to consider certain
205 issues related to the sponsor’s 586A request or pending request. (An NDAC meeting is not
206 meant to take the place of the public feedback meetings with CDER provided for elsewhere in
207 the SIA.22) Sponsors of 586A requests and pending requests that are interested in seeking an
208 NDAC meeting should submit their request for such meeting as early as possible in the process
209 to provide adequate time for the parties to prepare for the NDAC meeting.
211 The request for an NDAC meeting should be sent as a letter (either by hard copy or
212 electronically) to the Division of Nonprescription Drug Products (DNDP). If there is an
213 applicable docket, 23 a duplicate letter should be sent (either by hard copy or electronically) to the
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.
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
216 Food and Drug Administration
217 Division of Nonprescription Drug Products
218 Bldg. 22, Mail Stop 5411
219 10903 New Hampshire Avenue
220 Silver Spring, MD 20993
222 Food and Drug Administration
223 Division of Dockets Management (HFA-305)
224 5630 Fishers Lane, Rm. 1061
225 Rockville, MD 20852
226 Electronic letters should be submitted at http://www.regulations.gov in the applicable
227 docket.
229 We recommend the sponsor submit the following information as part of a request for an NDAC
230 meeting:
232 1. 233
235 2. 236
256 3. 257
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.
259 Upon receipt of the NDAC request,24 DNDP intends to review the letter. FDA intends to
260 consider an NDAC request to have been made when the Agency acknowledges receipt of the
261 request letter. DNDP intends to provide an acknowledgment letter to the sponsor within 30 days
262 of receipt. Acknowledgment of the receipt of the request does not constitute an agreement by
263 FDA to convene the NDAC. If FDA decides that the NDAC will be convened, FDA will notify
264 the sponsor.
266 Under the SIA, FDA may decide whether to convene an NDAC for any particular 586A request
267 or pending request regardless of whether the sponsor has made an NDAC request. FDA intends
268 to address and prioritize the total number of 586A requests and pending requests received by
269 using the factors described in Section II.A above to determine whether and when to refer such a
270 request to the NDAC. For example, FDA would be more likely to convene a meeting for matters
271 that are dissimilar to those discussed at a previous NDAC and for which a clear path forward had
272 not already been determined. In addition, FDA may convene an NDAC on its own initiative,
273 using similar criteria as those factors used to determine whether to present sponsor requests to an
274 NDAC.
276 As explained above, referring a matter to the NDAC involves a substantial expenditure of the
277 Agency’s limited resources and time. Accordingly, depending on the total number of 586A
278 requests and pending requests to be considered by the NDAC, FDA intends to limit the number
279 of NDAC meetings per year and the number of requests to be considered per meeting as
280 discussed in section 586C(c) of the FD&C Act.
283 IV. PREPARATION AND PUBLIC AVAILABILITY OF INFORMATION GIVEN TO
284 ADVISORY COMMITTEE MEMBERS
286 For each advisory committee meeting, the sponsor should provide briefing materials to be
287 considered by the members of the NDAC. For most meetings, these materials should consist of
288 the sponsor’s briefing document that addresses the issues to be considered by the NDAC, and the
289 sponsor’s slides to be presented. The briefing document should include all information relevant
290 to the matters to be discussed at the NDAC meeting, presented in a concise summary.
291 Information on briefing materials preparation, timelines and public availability of briefing
292 material information is included in the guidance for industry Advisory Committee Meetings –
293 Preparation and Public Availability of Information Given to Advisory Committee Members.25
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.