80 FR 72972 - Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 225 (November 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 225 (November 23, 2015)
| Page Range | 72972-72973 | |
| FR Document | 2015-29635 |
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)] [Notices] [Pages 72972-72973] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29635] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3990] Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is ``not'' required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the [[Page 72973]] instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-D-3990 for ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft 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 draft 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, 240-402- 4246. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This draft guidance provides background information on the sunscreen OTC monograph process, as well as on the Agency's intended process for convening the NDAC. It also recommends procedures for sponsors of 586A requests (submitted under section 586A of the FD&C Act (21 U.S.C. 360fff-1)) and for sponsors of pending requests (as defined by section 586(6) of the FD&C Act (21 U.S.C. 360fff (6))) to follow in requesting an NDAC meeting. This draft guidance also explains how FDA intends to process these requests and describes the factors the Agency may consider in determining whether and when to refer such requests to the NDAC. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the process by which the Agency will carry out section 586C(c) of the SIA (Pub. L. 113-195). 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. II. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. III. Paperwork Reduction Act of 1995 This draft guidance contains collections of information that are exempt from the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA). Section 586D(a)(1)(C) of the SIA states that the PRA shall not apply to collections of information made for purposes of guidance under section 586D(a). Dated: November 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29635 Filed 11-20-15; 8:45 am] BILLING CODE 4164-01-P
![72972 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices
Date and Time: The meeting will be Procedure: Interested persons may DEPARTMENT OF HEALTH AND
held on Friday, February 19, 2016, from present data, information, or views, HUMAN SERVICES
8 a.m. to 6 p.m. orally or in writing, on issues pending
Location: Hilton Washington, DC/ before the committee. Written Food and Drug Administration
North, Salons A, B, C, and D, 620 Perry submissions may be made to the contact [Docket No. FDA–2015–D–3990]
Pkwy., Gaithersburg, MD 20877. The person on or before February 12, 2016.
hotel telephone number is 301–977- Oral presentations from the public will Sunscreen Innovation Act: Section
8900. be scheduled between approximately 1 586C(c) Advisory Committee Process;
Contact Person: Sara Anderson, Draft Guidance for Industry;
Center for Devices and Radiological p.m. and 2 p.m. Those individuals
interested in making formal oral Availability
Health, Food and Drug Administration,
Bldg. 66, Rm.1643, 10903 New presentations should notify the contact AGENCY: Food and Drug Administration,
Hampshire Ave., Silver Spring, MD person and submit a brief statement of HHS.
20993, Sara.Anderson@fda.hhs.gov, 301 the general nature of the evidence or
ACTION: Notice of availability.
796–7047, or FDA Advisory Committee arguments they wish to present, the
Information Line, 1–800–741–8138 names and addresses of proposed SUMMARY: The Food and Drug
(301–443–0572 in the Washington, DC participants, and an indication of the Administration (FDA or Agency) is
area). A notice in the Federal Register approximate time requested to make announcing the availability of a draft
about last minute modifications that their presentation on or before February guidance for industry entitled
impact a previously announced 4, 2016. Time allotted for each ‘‘Sunscreen Innovation Act: Section
advisory committee meeting cannot presentation may be limited. If the 586C(c) Advisory Committee Process.’’
always be published quickly enough to number of registrants requesting to This draft guidance explains the process
provide timely notice. Therefore, you speak is greater than can be reasonably by which FDA intends to carry out the
should always check the Agency’s Web accommodated during the scheduled section of the Federal Food, Drug, and
site at http://www.fda.gov/ open public hearing session, FDA may Cosmetic Act (the FD&C Act), as
AdvisoryCommittees/default.htm and conduct a lottery to determine the amended by the Sunscreen Innovation
scroll down to the appropriate advisory speakers for the scheduled open public Act (SIA), which governs the convening
committee meeting link, or call the of advisory committees and the number
hearing session. The contact person will
advisory committee information line to of requests to be considered per
notify interested persons regarding their
learn about possible modifications meeting. The recommendations in this
before coming to the meeting. request to speak by February 5, 2016.
draft guidance apply to 586A requests
Agenda: The Committee will discuss Persons attending FDA’s advisory submitted under the FD&C Act and to
the premarket application for the DIAM committee meetings are advised that the pending requests as defined by the SIA
Spinal Stabilization System. The DIAM Agency is not responsible for providing that seek a determination from FDA on
Spinal Stabilization System is indicated access to electrical outlets. whether a nonprescription sunscreen
for skeletally mature patients that have active ingredient, or a combination of
FDA welcomes the attendance of the
low back pain (with or without nonprescription sunscreen active
public at its advisory committee
radicular pain) with current episode ingredients, is generally recognized as
lasting less than 1 year in duration meetings and will make every effort to
accommodate persons with disabilities. safe and effective for use under
secondary to moderate lumbar specified conditions and should be
degenerative disc disease (DDD) at a If you require accommodations due to a
disability, please contact AnnMarie included in the over-the-counter (OTC)
single level from L2–L5. DDD is sunscreen drug monograph. The SIA
confirmed radiographically with one or Williams at 301–796–5966 at least 7
describes specific circumstances under
more of the following factors: (1) days in advance of the meeting.
which FDA is ‘‘not’’ required to convene
Patients must have greater than 2 FDA is committed to the orderly or submit requests to the
millimeters of decreased disc height conduct of its advisory committee Nonprescription Drugs Advisory
compared to the adjacent level; (2) meetings. Please visit our Web site at Committee (NDAC). We are issuing this
scarring/thickening of the ligamentum http://www.fda.gov/ draft guidance pursuant to the SIA,
flavum, annulus fibrosis, or facet joint AdvisoryCommittees/ which directs FDA to issue four
capsule; or (3) herniated nucleus AboutAdvisoryCommittees/ guidances on various topics, including
pulposus. The DIAM device is ucm111462.htm for procedures on this draft guidance.
implanted via a minimally invasive
public conduct during advisory DATES: Although you can comment on
posterior approach.
FDA intends to make background committee meetings. any guidance at any time (see 21 CFR
material available to the public no later Notice of this meeting is given under 10.115(g)(5)), to ensure that the Agency
than 2 business days before the meeting. the Federal Advisory Committee Act (5 considers your comment on this draft
If FDA is unable to post the background U.S.C. app. 2). guidance before it begins work on the
material on its Web site prior to the final version of the guidance, submit
Dated: November 13, 2015. either electronic or written comments
meeting, the background material will
Jill Hartzler Warner, on the draft guidance by January 22,
be made publicly available at the
location of the advisory committee Associate Commissioner for Special Medical 2016.
meeting, and the background material Programs.
ADDRESSES: You may submit comments
wgreen on DSK2VPTVN1PROD with NOTICES
will be posted on FDA’s Web site after [FR Doc. 2015–29768 Filed 11–20–15; 8:45 am] as follows:
the meeting. Background material is BILLING CODE 4164–01–P
available at http://www.fda.gov/ Electronic Submissions
AdvisoryCommittees/Calendar/ Submit electronic comments in the
default.htm. Scroll down to the following way:
appropriate advisory committee meeting • Federal eRulemaking Portal: http://
link. www.regulations.gov. Follow the
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![Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices 72973
instructions for submitting comments. its consideration of comments. The 586A of the FD&C Act (21 U.S.C. 360fff–
Comments submitted electronically, second copy, which will have the 1)) and for sponsors of pending requests
including attachments, to http:// claimed confidential information (as defined by section 586(6) of the
www.regulations.gov will be posted to redacted/blacked out, will be available FD&C Act (21 U.S.C. 360fff (6))) to
the docket unchanged. Because your for public viewing and posted on http:// follow in requesting an NDAC meeting.
comment will be made public, you are www.regulations.gov. Submit both This draft guidance also explains how
solely responsible for ensuring that your copies to the Division of Dockets FDA intends to process these requests
comment does not include any Management. If you do not wish your and describes the factors the Agency
confidential information that you or a name and contact information to be may consider in determining whether
third party may not wish to be posted, made publicly available, you can and when to refer such requests to the
such as medical information, your or provide this information on the cover NDAC.
anyone else’s Social Security number, or sheet and not in the body of your This draft guidance is being issued
confidential business information, such comments and you must identify this consistent with FDA’s good guidance
as a manufacturing process. Please note information as ‘‘confidential.’’ Any practices regulation (21 CFR 10.115).
that if you include your name, contact information marked as ‘‘confidential’’ The draft guidance, when finalized, will
information, or other information that will not be disclosed except in represent the current thinking of FDA
identifies you in the body of your accordance with 21 CFR 10.20 and other on the process by which the Agency
comments, that information will be applicable disclosure law. For more will carry out section 586C(c) of the SIA
posted on http://www.regulations.gov. information about FDA’s posting of (Pub. L. 113–195). It does not establish
• If you want to submit a comment comments to public dockets, see 80 FR any rights for any person and is not
with confidential information that you 56469, September 18, 2015, or access binding on FDA or the public. You can
do not wish to be made available to the the information at: http://www.fda.gov/ use an alternative approach if it satisfies
public, submit the comment as a regulatoryinformation/dockets/ the requirements of the applicable
written/paper submission and in the default.htm. statutes and regulations.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). II. Electronic Access
read background documents or the
electronic and written/paper comments Persons with access to the Internet
Written/Paper Submissions
received, go to http:// may obtain the document at either
Submit written/paper submissions as www.regulations.gov and insert the http://www.fda.gov/Drugs/Guidance
follows: docket number, found in brackets in the ComplianceRegulatoryInformation/
• Mail/Hand delivery/Courier (for Guidances/default.htm or http://
heading of this document, into the
written/paper submissions): Division of www.regulations.gov.
‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
and/or go to the Division of Dockets III. Paperwork Reduction Act of 1995
and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. This draft guidance contains
• For written/paper comments 1061, Rockville, MD 20852.
Submit written requests for single collections of information that are
submitted to the Division of Dockets exempt from the Paperwork Reduction
copies of this draft guidance to the
Management, FDA will post your Act of 1995 (44 U.S.C. 3501–3520)
Division of Drug Information, Center for
comment, as well as any attachments, (PRA). Section 586D(a)(1)(C) of the SIA
Drug Evaluation and Research, Food
except for information submitted, states that the PRA shall not apply to
and Drug Administration, 10001 New
marked and identified, as confidential, collections of information made for
Hampshire Ave., Hillandale Building,
if submitted as detailed in purposes of guidance under section
4th Floor, Silver Spring, MD 20993–
‘‘Instructions.’’ 586D(a).
Instructions: All submissions received 0002. Send one self-addressed adhesive
label to assist that office in processing Dated: November 16, 2015.
must include the Docket No. FDA–
2015–D–3990 for ‘‘Sunscreen your requests. See the SUPPLEMENTARY Leslie Kux,
INFORMATION section for electronic Associate Commissioner for Policy.
Innovation Act: Section 586C(c)
Advisory Committee Process; Draft access to the draft guidance document. [FR Doc. 2015–29635 Filed 11–20–15; 8:45 am]
Guidance for Industry.’’ Received FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P
comments will be placed in the docket Kristen Hardin, Center for Drug
and, except for those submitted as Evaluation and Research, Food and
‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New DEPARTMENT OF HEALTH AND
viewable at http://www.regulations.gov Hampshire Ave., Bldg. 22, Rm. 5443, HUMAN SERVICES
or at the Division of Dockets Silver Spring, MD 20993, 240–402–
4246. Food and Drug Administration
Management between 9 a.m. and 4 p.m.,
Monday through Friday. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2015–D–4033]
• Confidential Submissions—To
submit a comment with confidential I. Background Sunscreen Innovation Act:
information that you do not wish to be FDA is announcing the availability of Nonprescription Sunscreen Drug
made publicly available, submit your a draft guidance for industry entitled Products—Content and Format of Data
comments only as a written/paper ‘‘Sunscreen Innovation Act: Section Submissions; Draft Guidance for
submission. You should submit two 586C(c) Advisory Committee Process.’’ Industry; Availability
wgreen on DSK2VPTVN1PROD with NOTICES
copies total. One copy will include the This draft guidance provides AGENCY: Food and Drug Administration,
information you claim to be confidential background information on the HHS.
with a heading or cover note that states sunscreen OTC monograph process, as ACTION: Notice of availability.
‘‘THIS DOCUMENT CONTAINS well as on the Agency’s intended
CONFIDENTIAL INFORMATION.’’ The process for convening the NDAC. It also SUMMARY: The Food and Drug
Agency will review this copy, including recommends procedures for sponsors of Administration (FDA or Agency) is
the claimed confidential information, in 586A requests (submitted under section announcing the availability of a draft
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Document Created: 2018-03-01 11:17:46
Document Modified: 2018-03-01 11:17:46
| 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 | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016. | |
| 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, 240-402- 4246. | |
| FR Citation | 80 FR 72972 |
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