Sunscreen Innovation Act: 
Withdrawal of a 586A Request 
or Pending Request  
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
   
 October 2016 
OTC
   
 
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 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov 
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) 
 
October 2016 
OTC 
  Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Regulation of Sunscreen Products ................................................................................................2 
B.  Section 586D(a) Guidance on Withdrawal Process .....................................................................4 
C.  Related Guidance ...........................................................................................................................5 
III.  GENERAL WITHDRAWAL PROCEDURES .............................................................. 5 
A.  Request for Withdrawal ................................................................................................................5 
B.  Withdrawal Due to Sponsors Failure to Take Action ................................................................6 
IV.  EFFECT OF WITHDRAWAL OF 586A REQUESTS AND PENDING 
REQUESTS ....................................................................................................................... 7 
A.  586A Request  Withdrawal ........................................................................................................8 
1. Withdrawal Prior to an Eligibility Determination or After a Determination That a 
Request Is Ineligible ........................................................................................................................8 
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 
B.  Pending Requests  Withdrawal ...............................................................................................10 
C.  New Requests ................................................................................................................................10 
 
  Contains Nonbinding Recommendations 
 
Sunscreen Innovation Act:  
Withdrawal of a 586A Request or  
Pending Request  
 
Guidance for Industry1 
 
 
 
This guidance represents 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 office responsible for this guidance as listed on the 
title page.  
 
 
 
I.  INTRODUCTION  
 
This guidance addresses the process for (1) withdrawal of a request submitted under section 
586A (586A request)2 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by 
Public Law 113-195 (also referred to as the Sunscreen Innovation Act or SIA)3 and (2) 
withdrawal of a pending request, as defined under section 586(6) of the FD&C Act.4  The 
recommendations in this guidance apply to 586A requests and pending requests that seek a 
determination from FDA of whether a nonprescription sunscreen active ingredient5 or a 
combination of nonprescription sunscreen active ingredients is generally recognized as safe and 
                                                 
1 This guidance has been prepared by the Office of Regulatory Policy in 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 were 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 FDAs 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))). 
 
1 
  Contains Nonbinding Recommendations 
effective (GRASE) for use under specified conditions and should be included in the over-the-
counter (OTC) sunscreen drug monograph. 
   
The SIA, enacted on November 26, 2014, added new section 586D(a)(1) to the FD&C Act (21 
U.S.C. 360fff-4(a)(1)), which directs FDA to issue draft and final guidance on the process by 
which a request under section 586A or a pending request is withdrawn.6  This guidance is 
organized as follows: 
 
  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 
sponsors 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. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND 
 
A.  Regulation of Sunscreen Products 
 
All sunscreens are regulated as drugs in the United States under one of two processes: 
 
  The new drug approval process described in part 314 (21 CFR part 314) 
 
                                                 
6  The draft guidance was issued in November 2015 (80 FR 72970, Nov. 23, 2015). 
 
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))). 
 
2 
  Contains Nonbinding Recommendations 
  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 
 
Products regulated under the new drug approval process may not be marketed without FDAs 
prior review and approval of a new drug application (NDA) or abbreviated new drug application 
(ANDA) for each product.9  Products marketed under the OTC drug monograph process are not 
individually reviewed and approved prior to marketing.  Instead, OTC drug monographs 
categorize drugs by therapeutic categories, such as sunscreens.  For each category, a monograph 
establishes conditions under which any drug that satisfies those conditions and FDAs general 
regulations for OTC drugs is considered to be GRASE and not misbranded when used under the 
conditions prescribed, recommended, or suggested in the drugs labeling.10  
 
Active ingredients that were used in U.S.-marketed sunscreens before the OTC Drug Review  
began are eligible to be included in the OTC sunscreen monograph.  An active ingredient or 
other condition that is ineligible for inclusion in the OTC monograph system is subject to the 
new drug approval process.  
 
In 2002, before the SIA was enacted, FDA published the time and extent application (TEA) 
regulation in 21 CFR 330.14.  The TEA regulation ( 330.14(c)) has provided a process through 
which any person may request that FDA amend an existing OTC drug monograph to include an 
active ingredient or other OTC drug condition, including one not previously marketed in the 
United States before the OTC Drug Review began.         
 
For OTC sunscreens, the SIA process supplements FDAs TEA regulation ( 330.14).  The SIA 
amended the FD&C Act in part by providing new procedures for establishing that 
nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active 
ingredients are GRASE and not misbranded when used under the conditions specified in a final 
sunscreen order (GRASE determination).11  Active ingredients that are determined to be GRASE 
under specified conditions of use in a final sunscreen order may be used in U.S.-marketed 
sunscreens without first obtaining an approved NDA or ANDA.  Because the monograph and 
SIA processes are public, anyone, not just the sponsor who originated the request, may submit 
data during public comment periods.   
 
As with the TEA process, the SIA process calls for an initial eligibility determination, followed 
by submissions of safety and efficacy data, and a GRASE determination phase.  However, the 
SIA process also requires FDA to make a filing determination12 and to make proposed and final 
GRASE determinations in the form of orders rather than the rulemaking required by the TEA 
                                                 
9 See sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). 
 
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))). 
 
3 
  Contains Nonbinding Recommendations 
regulation.  The SIA process also establishes strict timelines for the necessary administrative 
actions. 
  
 
B.  Section 586D(a) Guidance on Withdrawal Process 
 
Section 586D(a)(1)(A)(iii) of the FD&C Act requires the Agency to issue guidance on the 
process by which a request under section 586A or a pending request is withdrawn.13  The 
statute does not address the process by which a sponsor or FDA could withdraw a 586A request 
or pending request under the SIA.  In addition, FDAs current regulations governing TEA 
requests do not include a withdrawal process ( 330.14).14  As directed by the SIA, FDA is 
issuing this guidance to explain how, at different stages of the SIA process, a 586A request or 
pending request may be withdrawn.   
 
Although neither the SIA nor the current TEA regulation otherwise discuss the process of 
withdrawal, we note that in the preamble of the final rule promulgating the TEA regulation, FDA 
discussed the effect of a withdrawal of a TEA request when a non-GRASE determination for that 
condition is expected.  We explained in the preamble to the 2002 TEA Final Rule that although a 
sponsor can withdraw its request after receiving a feedback letter indicating that a condition has 
been determined not to be GRASE, we would still consider the submission, including the data 
and information submitted, to be a part of the public docket and FDA would still have the 
discretion to publish the Agencys non-GRASE decision, notwithstanding the withdrawal.15  As 
indicated in the preamble to the 2002 TEA Final Rule, it is the Agencys view that the OTC 
Drug Review  is a public process, and thus, if a condition is determined to be eligible for review, 
all information provided to FDA should remain part of the public record, even if a sponsor 
withdraws its request.16  The SIA process, like the OTC Drug Review, is also a public process.  
Thus, consistent with the 2002 TEA Final Rule and as explained in Section III of this guidance, 
the Agency may continue to rely on the data and information that have been submitted in the SIA 
process after a request is withdrawn.  
 
Based on the requirements of the SIA and the Agencys prior consideration of a similar issue in 
implementing the TEA regulation,17 this guidance describes our recommendations for addressing 
                                                 
13 Section 586C(a)(1)(A)(iii) of the FD&C Act (21 U.S.C. 360fff-3(a)(1)(A)(iii)).   
 
14 We note that on April 4, 2016, the Agency issued a proposed rulemaking that proposes to revise section 330.14 of 
the Agencys regulations to include provisions regarding the withdrawal of TEAs and safety and effectiveness data 
submissions (81 FR 19069, April 4, 2016).  
 
15 See Additional Criteria and Procedures for Classifying Over-the Counter Drugs as Generally Recognized as Safe 
and Effective and Not Misbranded (2002 TEA Final Rule), 67 FR 3060 at 3066 and 3067 (January 23, 2002).   
 
16  There may be limited situations in which certain information submitted may be considered confidential.  See 
2002 TEA Final Rule, 67 FR 3060 at 3067 and 3066; see also section 586B(a)(3) of the FD&C Act (21 U.S.C. 
360fff-2(a)(3)). 
 
17 See 2002 TEA Final Rule, 67 FR 3060 at 3067. 
 
4 
  Contains Nonbinding Recommendations 
the process for withdrawal of a 586A request or pending request and the effect of a withdrawal 
on the GRASE review process.  
 
C.  Related Guidance 
 
In addition to this guidance, the SIA directs FDA to issue draft and final guidance documents on 
three other topics.18  These topics include: 
 
  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 
 
  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.  
 
In November 2015, FDA issued draft guidance on all four topics.  As they become available 
draft or final guidances are posted on the FDA Drugs guidance Web page at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
19     
 
 
III.  GENERAL WITHDRAWAL PROCEDURES 
 
A.  Request for Withdrawal 
 
A sponsor seeking to withdraw its 586A request or pending request should submit its written or 
electronic request for withdrawal to the docket with a copy to the Division of Nonprescription 
Drug Products in the Office of Drug Evaluation IV.20  Written requests should be submitted to: 
 
Division of Dockets Management (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane, Rm. 1061 
                                                 
18 Section 586D(a)(1)(A) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)). 
 
19 When available, FDA will post each final guidance on the FDA Drugs guidance Web page at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
   
20 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 in 
this guidance. 
 
5 
  Contains Nonbinding Recommendations 
Rockville, MD 20852 
and 
Food and Drug Administration 
Division of Nonprescription Drug Products 
Bldg. 22, Mail Stop 5411 
10903 New Hampshire Avenue 
Silver Spring, MD 20993 
 
Electronic requests, and electronic copies of written requests, should be submitted to 
http://www.regulations.gov in the applicable docket.  The withdrawal request should include the 
following information: 
  submitter  
  submission date 
  active ingredient or other condition that is the subject of the submission  
  applicable docket number 
 
A request to withdraw informs FDA of the sponsors intent to discontinue its request for a 
determination from the Agency of whether the sunscreen active ingredient, or combination of 
active ingredients, is GRASE and should be included in the sunscreen OTC monograph.  FDA 
intends to respond to a request for withdrawal from the sponsor by sending a letter to the sponsor 
acknowledging the withdrawal of the request.  If the withdrawal is made after a docket has been 
opened for that proceeding, FDA intends to place a copy of the acknowledgement letter in that 
docket.    
 
As explained in more detail below, generally, if a sponsor submits a request to withdraw its 
586A or pending request at any time prior to FDAs issuance of a final sunscreen order, FDA 
intends to consider the request withdrawn.  If a proposed sunscreen order has not been issued, 
FDA intends to stop its review of that request.  However, similar to FDAs approach under the 
TEA regulation, if a proposed sunscreen order has already been issued prior to the withdrawal, 
FDA may proceed with issuing a final sunscreen order consistent with the SIA and as priorities 
and resources permit.  In addition, FDA intends that the original submission and the data and 
information submitted in support of the 586A request will remain a part of the public docket for 
that proceeding, and FDA may continue to rely on such data and information.21  
 
 
B.  Withdrawal Due to Sponsors Failure to Take Action 
 
We note that there are several stages in the review process for 586A requests and pending 
requests at which the Agency will be waiting for the sponsor or other interested parties to submit 
necessary information or data.  With the exception of designated comment periods, the SIA does 
not require the sponsor or others to submit such information or data within an established 
                                                 
21 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.   
 
6 
  Contains Nonbinding Recommendations 
deadline.  Based on our past experience with the OTC monograph process, this may create a 
situation in which the necessary information or data are never submitted.     
 
Accordingly, we recommend that sponsors keep us apprised of the anticipated timing of their 
data submissions if those submissions are expected to occur more than 1 year from the date of 
the notice of eligibility (NOE) or the sponsors most recent submission.  To facilitate the review 
process and better utilize the Agencys time and resources, FDA may also request periodic 
updates from the sponsor on the status of the information or data to be submitted if nothing has 
been submitted by the sponsor for more than 1 year.  If an update is not provided or no 
information or data are submitted to FDA within 90 days of FDAs request for an update, the 
Agency intends to consider the sponsors failure to respond to be a request by the sponsor to 
withdraw the 586A or pending request.  By failing to take action, the sponsor will have indicated 
that it is no longer interested in pursuing a GRASE determination for a particular request.  FDA 
intends to send a letter notifying the sponsor that the request is withdrawn, and FDA intends to 
place a copy of the letter in the public docket for that proceeding.  It is the Agencys view that 
this withdrawal process will provide notice to the public of the status of the proceeding and of 
our intent to stop review of the request due to the sponsors failure to take action.  As discussed 
in section IV.C, if a 586A request or pending request is withdrawn, a sponsor can submit a new 
request for the same sunscreen active ingredient or combination of sunscreen active ingredients.  
 
 
IV.  EFFECT OF WITHDRAWAL OF 586A REQUESTS AND PENDING REQUESTS 
 
As explained above, the SIA process calls for an initial eligibility determination phase followed 
by the submission of safety and efficacy data, a filing determination by FDA, and a GRASE 
determination phase, which includes a proposed sunscreen order and final sunscreen order.   
 
If a 586A request is determined to be eligible for review, the Agency opens a docket for the 
proceeding, publicly posts the NOE and the 586A request,22 and provides interested parties 45 
days to submit comments relating to a GRASE determination on the request, including data and 
other information related to the safety and efficacy of the request.23 
 
A key step in the SIA process requires FDA to determine whether the information and data 
submitted to support a GRASE determination are appropriately formatted and sufficiently 
complete to support a substantive GRASE review (filing determination).24  Based on that 
determination, FDA will either file or refuse to file the request (thus triggering various action 
timelines).25   
 
                                                 
22 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)).   
 
23 Section 586B(b)(1) of the FD&C Act (21 U.S.C. 360fff-2(b)(1)). 
 
24 Section 586B(b)(2) of the FD&C Act (21 U.S.C. 360fff-2(b)(2)). 
 
25 Section 586B(b)(3) of the FD&C Act (21 U.S.C. 360fff-2(b)(3)).     
 
7 
  Contains Nonbinding Recommendations 
The following sections address the effect that a withdrawal of a 586A request or pending request 
may have on these and other key phases of the SIA process.  
 
 
A.  586A Request  Withdrawal   
 
1.  Withdrawal Prior to an Eligibility Determination or After a Determination That a 
Request Is Ineligible 
 
If a sponsor withdraws its 586A request before FDA issues a determination that the request is 
eligible for review, we intend to stop our review of the request because we no longer have a 
586A request upon which to make a determination of eligibility.  Similarly, if FDA has made a 
determination that the 586A request is not eligible for review under the SIA process, the matter 
may be considered closed without the need for a withdrawal because there is no longer an open 
matter from which to withdraw.  For requests withdrawn prior to an eligibility determination, 
FDA does not intend to publicly post the withdrawal notification.    
 
2.  Withdrawal After an Eligibility Determination but Prior to a Filing 
Determination   
 
a.  Presubmission of Data Package 
 
If a sponsor withdraws its 586A request after FDA has determined that the request is eligible for 
review and has issued an NOE, but before the data package described in section 586B(b)(1) of 
the FD&C Act has been submitted, FDA intends to stop its review of the withdrawn request.  
Upon the sponsors withdrawal, there will be no 586A request which may be filed.  If a new 
586A request is submitted for the same sunscreen active ingredient or combination of sunscreen 
active ingredients after the withdrawal of the original request, we intend to follow the process for 
the new request as explained in section IV.C of this guidance.   
 
b.  Postsubmission of Data Package  
 
If a sponsor withdraws its 586A request after FDA has determined that the request is eligible for 
review and has issued an NOE determination, and after the data package described in section 
586B(b)(1) of the FD&C Act has been submitted, but prior to FDAs filing determination, the 
Agency intends to stop its review of the 586A request.  Upon the sponsors withdrawal, there 
will be no 586A request.  If a new 586A request is submitted for the same sunscreen active 
ingredient or combination of sunscreen active ingredients after the withdrawal of the original 
request, we intend to follow the process for the new request as explained in section IV.C of this 
guidance.   
      
3.  Withdrawal After Filing Determination 
 
8 
  Contains Nonbinding Recommendations 
a.  Filed 586A Request 
 
If FDA determines that the data and information are sufficiently complete to conduct a GRASE 
review, the Agency will file the 586A request.  If a sponsor withdraws its 586A request after the 
Agency has filed the request and before the Agency has issued the proposed sunscreen order, the 
Agency intends to stop its review of the withdrawn request.  If a new 586A request is submitted 
for the same sunscreen active ingredient or combination of sunscreen active ingredients after the 
withdrawal of the original request, we intend to follow the process for the new request as 
explained in section IV.C of this guidance.   
 
b.  Refuse to File 
 
If a sponsor withdraws its 586A request after FDA refuses to file the request, the Agency intends 
to stop its review of the withdrawn request. A sponsor can submit additional data or other 
information in response to a refuse to file.  If a sponsor withdraws its 586A request after it has 
submitted additional data or information, but before FDA has made a new filing determination, 
the Agency intends to stop its review of the withdrawn request.26  If a new 586A request is 
submitted for the same sunscreen active ingredient or combination of sunscreen active 
ingredients after FDA refuses to file the original 586A request, we intend to follow the process 
for the new request as explained in section IV.C of this guidance.   
 
4.  Withdrawal After a Proposed Sunscreen Order Under Section 586(7)(C)  
 
If a sponsor withdraws the 586A request after the Agency has issued a proposed sunscreen order 
and has made a tentative determination on whether or not an active ingredient is GRASE under 
certain conditions of use, 27 FDA intends to deem the 586A request withdrawn, but may continue 
to rely on the information submitted to the docket and may proceed to issuing a final sunscreen 
order.  As explained in section II.B, we consider all data and information submitted (e.g., in 
response to the NOE, a feedback letter, or tentative GRASE determination) to be part of the 
public record.  Upon submission of such information, the Agency has the data upon which to 
base its final sunscreen order notwithstanding the withdrawal.  If a new 586A request is 
submitted for the same sunscreen active ingredient or combination of sunscreen active 
ingredients after the withdrawal of the original request, we intend to follow the process for the 
new request as explained in section IV.C of this guidance.   
 
                                                 
26  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 of this guidance. 
   
27 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))). 
 
9 
  Contains Nonbinding Recommendations 
   
B.  Pending Requests  Withdrawal 
 
As explained above, a pending request under the SIA is defined to mean a request for a 
nonprescription sunscreen active ingredient submitted under  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 were submitted prior to the enactment of the SIA (section 586(6) of 
the FD&C Act).  There are eight pending requests as defined under section 586(6) of the FD&C 
Act.  FDA has issued proposed sunscreen orders for all eight pending requests,28 and the 
proposed orders tentatively determined that the active ingredients are not GRASE and more data 
are necessary to allow FDA to determine otherwise.29 
 
Accordingly, FDA intends for the same withdrawal process described in section IV.A.4 to apply 
if a sponsor of a pending request withdraws the pending request prior to the issuance of the final 
sunscreen order.  If a new 586A request is submitted for the same sunscreen active ingredient 
after the withdrawal of the pending request, we intend to follow the process for the new request 
as explained in section IV.C of this guidance.   
  
C.  New Requests 
 
The same or a different sponsor can submit a new 586A request for the same sunscreen active 
ingredient or combination of sunscreen active ingredients after the original request has been 
withdrawn.  If FDA has already made a determination that the active ingredient is eligible for 
further review under the SIA process, FDA intends for the existing NOE to remain in effect and 
the sunscreen active ingredient or combination of active ingredients to remain eligible for 
consideration under the SIA.  The sponsor of the new 586A request may rely on the existing 
NOE for that active ingredient; but, thereafter, we intend to treat the new submission as a new 
586A request under the SIA process, and the sponsor should submit a new and complete data 
submission package for its request.  The data package may include data and other information 
that were submitted as part of a prior 586A or pending request for that ingredient under the SIA.  
If there is no existing NOE or the active ingredient has been found ineligible, then we intend to 
treat the submission of another 586A request for this ingredient as a new 586A request subject to 
the full SIA process, including an eligibility determination.      
 
                                                 
28 Section 586C(b)(3) of the FD&C Act (21 U.S.C. 360fff-3(b)(3)). 
 
29 See http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-
the-CounterMedicines/ucm239463.htm.  
10