83 FR 23917 - Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 100 (May 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 100 (May 23, 2018)
| Page Range | 23917-23918 | |
| FR Document | 2018-10994 |
[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)] [Notices] [Pages 23917-23918] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICE Food and Drug Administration [Docket No. FDA-2010-D-0509] Enforcement Policy--Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011. DATES: The announcement of the guidance is published in the Federal Register on May 23, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or [[Page 23918]] confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2010-D-0509 for ``Enforcement Policy--Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240- 402-4246. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance applies to OTC sunscreen products marketed without approved applications and describes FDA's approach to enforcement for these products until a final OTC sunscreen monograph becomes effective. This guidance finalizes a draft guidance that was issued under the same title on June 17, 2011 (76 FR 35665) and reflects FDA's consideration of public comments on the draft guidance. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the enforcement policy for OTC sunscreen drug products marketed without an approved application. 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) and under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 201.327 and 201.66, and 21 CFR part 330 have been approved under OMB control numbers 0910-0717, 0910- 0340, and 0910-0688, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10994 Filed 5-22-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices 23917
please reference the document identifier quality, accessibility, and affordability 37,407; Total Annual Hours: 44,817.
or OMB control number. To be assured in healthcare. CMS also aims to put (For policy questions regarding this
consideration, comments and patients first in the delivery of their collection contact William Long at 410–
recommendations must be received by health care needs. 786–7927.)
the OMB desk officer via one of the The Medicare Current Beneficiary Dated: May 18, 2018.
following transmissions: OMB, Office of Survey (MCBS) is the most
William N. Parham, III,
Information and Regulatory Affairs, comprehensive and complete Survey
available on the Medicare population Director, Paperwork Reduction Staff, Office
Attention: CMS Desk Officer, Fax of Strategic Operations and Regulatory
Number: (202) 395–5806 OR, Email: and is essential in capturing data not
Affairs.
OIRA_submission@omb.eop.gov. otherwise collected through our
[FR Doc. 2018–11056 Filed 5–22–18; 8:45 am]
To obtain copies of a supporting operations. The MCBS is an in-person,
BILLING CODE 4120–01–P
statement and any related forms for the nationally-representative, longitudinal
proposed collection(s) summarized in survey of Medicare beneficiaries that we
this notice, you may make your request sponsor and is directed by the Office of
DEPARTMENT OF HEALTH AND
using one of following: Enterprise Data and Analytics (OEDA).
The survey captures beneficiary HUMAN SERVICE
1. Access CMS’ website address at
http://www.cms.hhs.gov/ information whether aged or disabled, Food and Drug Administration
PaperworkReductionActof1995. living in the community or facility, or
2. Email your request, including your serviced by managed care or fee-for- [Docket No. FDA–2010–D–0509]
address, phone number, OMB number, service. Data produced as part of the
and CMS document identifier, to MCBS are enhanced with our Enforcement Policy—Over-the-Counter
Paperwork@cms.hhs.gov. administrative data (e.g., fee-for-service Sunscreen Drug Products Marketed
3. Call the Reports Clearance Office at claims, prescription drug event data, Without an Approved Application;
(410) 786–1326. enrollment, etc.) to provide users with Guidance for Industry; Availability
FOR FURTHER INFORMATION CONTACT: more accurate and complete estimates of AGENCY: Food and Drug Administration,
Reports Clearance Office at (410) 786– total health care costs and utilization. HHS.
1326. The MCBS has been continuously
ACTION: Notification of availability.
fielded for more than 25 years,
SUPPLEMENTARY INFORMATION: Under the encompassing over 1 million interviews
Paperwork Reduction Act of 1995 (PRA) SUMMARY: The Food and Drug
and more than 100,000 survey Administration (FDA or Agency) is
(44 U.S.C. 3501–3520), federal agencies participants. Respondents participate in
must obtain approval from the Office of announcing the availability of a
up to 11 interviews over a three and a guidance for industry entitled
Management and Budget (OMB) for each half year period. This gives a
collection of information they conduct ‘‘Enforcement Policy—OTC Sunscreen
comprehensive picture of health care Drug Products Marketed Without an
or sponsor. The term ‘‘collection of costs and utilization over a period of
information’’ is defined in 44 U.S.C. Approved Application.’’ This guidance
time. describes FDA’s approach to
3502(3) and 5 CFR 1320.3(c) and The MCBS continues to provide
includes agency requests or enforcement for over-the-counter (OTC)
unique insight into the Medicare sunscreen products marketed without
requirements that members of the public program and helps CMS and our
submit reports, keep records, or provide approved applications before a final
external stakeholders better understand OTC sunscreen drug monograph
information to a third party. Section and evaluate the impact of existing
3506(c)(2)(A) of the PRA (44 U.S.C. becomes effective. This guidance
programs and significant new policy
3506(c)(2)(A)) requires federal agencies finalizes the draft guidance of the same
initiatives. In the past, MCBS data have
to publish a 30-day notice in the name issued June 17, 2011.
been used to assess potential changes to
Federal Register concerning each the Medicare program. For example, the DATES: The announcement of the
proposed collection of information, MCBS was instrumental in supporting guidance is published in the Federal
including each proposed extension or the development and implementation of Register on May 23, 2018.
reinstatement of an existing collection the Medicare prescription drug benefit ADDRESSES: You may submit either
of information, before submitting the by providing a means to evaluate electronic or written comments on
collection to OMB for approval. To prescription drug costs and out-of- Agency guidances at any time as
comply with this requirement, CMS is pocket burden for these drugs to follows:
publishing this notice that summarizes Medicare beneficiaries. Beginning in
the following proposed collection(s) of Electronic Submissions
2019, this proposed revision to the
information for public comment: clearance will eliminate or streamline Submit electronic comments in the
1. Type of Information Collection some questionnaire sections, add a few following way:
Request: Revision of a currently new measures, take advantage of • Federal eRulemaking Portal:
approved collection; Title of administrative data to reduce the https://www.regulations.gov. Follow the
Information Collection: Medicare number of survey questions in some instructions for submitting comments.
Current Beneficiary Survey; Use: CMS is long term care facilities, and Comments submitted electronically,
the largest single payer of health care in discontinue the 12th interview as had including attachments, to https://
the United States. The agency plays a previously been collected. The revisions www.regulations.gov will be posted to
direct or indirect role in administering will result in an overall reduction in the docket unchanged. Because your
daltland on DSKBBV9HB2PROD with NOTICES
health insurance coverage for more than respondent burden by 25%. Form comment will be made public, you are
120 million people across the Medicare, Number: CMS–P–0015A (OMB control solely responsible for ensuring that your
Medicaid, CHIP, and Exchange number: 0938–0568); Frequency: comment does not include any
populations. A critical aim for CMS is Occasionally; Affected Public: Business confidential information that you or a
to be an effective steward, major force, or other for-profits and Not-for-profit third party may not wish to be posted,
and trustworthy partner in supporting institutions; Number of Respondents: such as medical information, your or
innovative approaches to improving 14,146; Total Annual Responses: anyone else’s Social Security number, or
VerDate Sep<11>2014 17:33 May 22, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1](https://thefederalregister.org/doc/83_FR_24017/page/1.svg)
![23918 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices
confidential business information, such must identify this information as policy for OTC sunscreen drug products
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked marketed without an approved
that if you include your name, contact as ‘‘confidential’’ will not be disclosed application. It does not establish any
information, or other information that except in accordance with 21 CFR 10.20 rights for any person and is not binding
identifies you in the body of your and other applicable disclosure law. For on FDA or the public. You can use an
comments, that information will be more information about FDA’s posting alternative approach if it satisfies the
posted on https://www.regulations.gov. of comments to public dockets, see 80 requirements of the applicable statutes
• If you want to submit a comment FR 56469, September 18, 2015, or access and regulations. This guidance is not
with confidential information that you the information at: https://www.gpo.gov/ subject to Executive Order 12866.
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a II. Paperwork Reduction Act of 1995
23389.pdf.
written/paper submission and in the Docket: For access to the docket to This guidance refers to previously
manner detailed (see ‘‘Written/Paper read background documents or the approved collections of information
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments found in FDA regulations. These
Written/Paper Submissions received, go to https:// collections of information are subject to
www.regulations.gov and insert the review by the Office of Management and
Submit written/paper submissions as docket number, found in brackets in the Budget (OMB) and under the Paperwork
follows: heading of this document, into the Reduction Act of 1995 (44 U.S.C. 3501–
• Mail/Hand delivery/Courier (for 3520). The collections of information in
‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets 21 CFR 201.327 and 201.66, and 21 CFR
and/or go to the Dockets Management
Management Staff (HFA–305), Food and part 330 have been approved under
Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers OMB control numbers 0910–0717,
Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. 0910–0340, and 0910–0688,
• For written/paper comments You may submit comments on any
guidance at any time (see 21 CFR respectively.
submitted to the Dockets Management
Staff, FDA will post your comment, as 10.115(g)(5)). III. Electronic Access
well as any attachments, except for Submit written requests for single
copies of this guidance to the Division Persons with access to the internet
information submitted, marked and may obtain the guidance at either http://
identified, as confidential, if submitted of Drug Information, Center for Drug
Evaluation and Research, Food and www.fda.gov/Drugs/Guidance
as detailed in ‘‘Instructions.’’ ComplianceRegulatoryInformation/
Instructions: All submissions received Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, Guidances/default.htm or https://
must include the Docket No. FDA–
4th Floor, Silver Spring, MD 20993– www.regulations.gov.
2010–D–0509 for ‘‘Enforcement Policy—
Over-the-Counter Sunscreen Drug 0002. Send one self-addressed adhesive Dated: May 17, 2018.
Products Marketed Without an label to assist that office in processing Leslie Kux,
Approved Application; Guidance for your requests. See the SUPPLEMENTARY Associate Commissioner for Policy.
Industry; Availability.’’ Received INFORMATION section for electronic
[FR Doc. 2018–10994 Filed 5–22–18; 8:45 am]
comments will be placed in the docket access to the guidance document.
BILLING CODE 4164–01–P
and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
‘‘Confidential Submissions,’’ publicly Kristen Hardin, Center for Drug
viewable at https://www.regulations.gov Evaluation and Research, Food and DEPARTMENT OF HEALTH AND
or at the Dockets Management Staff Drug Administration, 10903 New HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 22, Rm. 5443,
through Friday. Silver Spring, MD 20993–0002, 240– Food and Drug Administration
• Confidential Submissions—To 402–4246.
submit a comment with confidential [Docket No. FDA–2018–D–1456]
SUPPLEMENTARY INFORMATION:
information that you do not wish to be
I. Background Maximal Usage Trials for Topical
made publicly available, submit your
Active Ingredients Being Considered
comments only as a written/paper FDA is announcing the availability of
for Inclusion in an Over-the-Counter
submission. You should submit two a guidance for industry entitled
Monograph: Study Elements and
copies total. One copy will include the ‘‘Enforcement Policy—OTC Sunscreen
Considerations; Draft Guidance for
information you claim to be confidential Drug Products Marketed Without an
Industry; Availability
with a heading or cover note that states Approved Application.’’ This guidance
‘‘THIS DOCUMENT CONTAINS applies to OTC sunscreen products AGENCY: Food and Drug Administration,
CONFIDENTIAL INFORMATION.’’ The marketed without approved HHS.
Agency will review this copy, including applications and describes FDA’s ACTION: Notice of availability.
the claimed confidential information, in approach to enforcement for these
its consideration of comments. The products until a final OTC sunscreen SUMMARY: The Food and Drug
second copy, which will have the monograph becomes effective. This Administration (FDA or Agency) is
claimed confidential information guidance finalizes a draft guidance that announcing the availability of a draft
redacted/blacked out, will be available was issued under the same title on June guidance for industry entitled ‘‘Maximal
for public viewing and posted on 17, 2011 (76 FR 35665) and reflects Usage Trials for Topical Active
daltland on DSKBBV9HB2PROD with NOTICES
https://www.regulations.gov. Submit FDA’s consideration of public Ingredients Being Considered for
both copies to the Dockets Management comments on the draft guidance. Inclusion in an Over-the-Counter
Staff. If you do not wish your name and This guidance is being issued Monograph: Study Elements and
contact information to be made publicly consistent with FDA’s good guidance Considerations.’’ This draft guidance
available, you can provide this practices regulation (21 CFR 10.115). addresses FDA’s current thinking on the
information on the cover sheet and not The guidance represents the current conduct of in vivo absorption trials for
in the body of your comments and you thinking of FDA on the enforcement topical active ingredients that are under
VerDate Sep<11>2014 17:33 May 22, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1](https://thefederalregister.org/doc/83_FR_24017/page/2.svg)
Document Created: 2018-05-22 23:48:50
Document Modified: 2018-05-22 23:48:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on May 23, 2018. | |
| Contact | Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240- 402-4246. | |
| FR Citation | 83 FR 23917 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR