81 FR 940 - Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 5 (January 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 5 (January 8, 2016)
| Page Range | 940-941 | |
| FR Document | 2016-00128 |
[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)] [Notices] [Pages 940-941] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00128] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4021] Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability'' that appeared in the Federal Register on November 23, 2015 (80 FR 72975). That notice announced the availability of a draft guidance for industry and requested comments to that draft guidance by January 22, 2016. FDA is extending the draft guidance's comment period by 30 days (to February 22, 2016) in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period for the draft guidance by an additional 30 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by February 22, 2016.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 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-4021 for ``Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry.'' [[Page 941]] 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 the 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 20993-0002, 240- 402-4246. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 23, 2015 (80 FR 72975), FDA published a notice of availability with a 60-day comment period for the draft guidance for industry entitled ``Over-the-Counter Sunscreens: Safety and Effectiveness Data.'' Publication of that draft guidance was mandated by the Sunscreen Innovation Act (SIA), which also requires FDA to publish the final guidance no later than November 26, 2016. The Agency has received a request for a 30-day extension of the comment period to provide more time for regulated industry to prepare a detailed and meaningful response to the draft guidance. FDA has considered the request and is extending the comment period for 30 days, until February 22, 2016. The Agency believes that a 30-day extension will allow adequate time for interested persons to submit comments without compromising timely publication of the final guidance as mandated by the SIA. II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: January 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00128 Filed 1-7-16; 8:45 am] BILLING CODE 4164-01-P
![940 Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices
became effective. Some examples of the public hearing session. The contact extension to allow interested persons
means by which these devices perform person will notify interested persons additional time to submit comments.
these functions and their respective regarding their request to speak by DATES: FDA is extending the comment
IFU/IU statements are: February 10, 2016. period for the draft guidance by an
• Utilizes a continuous flow Persons attending FDA’s advisory additional 30 days. Although you can
centrifuge (max speed 3000 revolutions committee meetings are advised that the comment on any guidance at any time
per minute) to separate source blood Agency is not responsible for providing (see 21 CFR 10.115(g)(5)), to permit the
from a subject into blood components. access to electrical outlets. Agency to consider your comments
Æ IFU/IU: May be used to perform FDA welcomes the attendance of the before issuing the final version of the
therapeutic plasma exchange. public at its advisory committee guidance, submit either electronic or
Æ IFU/IU: May be used to perform meetings and will make every effort to written comments on the draft guidance
Red Blood Cell Exchange procedures for accommodate persons with disabilities. by February 22, 2016.
the transfusion management of Sickle If you require accommodations due to a
Cell Disease in adults and children. ADDRESSES: You may submit comments
disability, please contact AnnMarie
• Uses continuous flow access to a Williams at
as follows:
rotating centrifuge to separate blood annmarie.williams@fda.hhs.gov, 301– Electronic Submissions
components. 796–5966, at least 7 days in advance of
Æ IFU/IU: May be used to harvest Submit electronic comments in the
the meeting. following way:
cellular components from the blood of
FDA is committed to the orderly • Federal eRulemaking Portal: http://
certain patients where the attending
conduct of its advisory committee www.regulations.gov. Follow the
physician feels the removal of such
component may benefit the patient. meetings. Please visit our Web site at instructions for submitting comments.
Æ IFU/IU: May be used to remove http://www.fda.gov/Advisory Comments submitted electronically,
plasma components and/or fluid Committees/AboutAdvisoryCommittees/ including attachments, to http://
selected by the attending physicians. ucm111462.htm for procedures on www.regulations.gov will be posted to
FDA intends to make background public conduct during advisory the docket unchanged. Because your
material available to the public no later committee meetings. comment will be made public, you are
than 2 business days before the meeting. Notice of this meeting is given under solely responsible for ensuring that your
If FDA is unable to post the background the Federal Advisory Committee Act (5 comment does not include any
material on its Web site prior to the U.S.C. app. 2). confidential information that you or a
meeting, the background material will Dated: January 4, 2016. third party may not wish to be posted,
be made publicly available at the Jill Hartzler Warner, such as medical information, your or
location of the advisory committee Associate Commissioner for Special Medical anyone else’s Social Security number, or
meeting, and the background material Programs. confidential business information, such
will be posted on FDA’s Web site after [FR Doc. 2016–00111 Filed 1–7–16; 8:45 am] as a manufacturing process. Please note
the meeting. Background material is BILLING CODE 4164–01–P
that if you include your name, contact
available at http://www.fda.gov/ information, or other information that
AdvisoryCommittees/Calendar/ identifies you in the body of your
default.htm and then by scrolling down DEPARTMENT OF HEALTH AND comments, that information will be
to the appropriate advisory committee HUMAN SERVICES posted on http://www.regulations.gov.
meeting link. • If you want to submit a comment
Procedure: Interested persons may Food and Drug Administration with confidential information that you
present data, information, or views, do not wish to be made available to the
orally or in writing, on issues pending [Docket No. FDA–2015–D–4021]
public, submit the comment as a
before the committee. Written written/paper submission and in the
Over-the-Counter Sunscreens: Safety
submissions may be made to the contact manner detailed (see ‘‘Written/Paper
and Effectiveness Data; Draft
person on or before February 17, 2016. Submissions’’ and ‘‘Instructions’’).
Guidance for Industry; Extension of
Oral presentations from the public will
Comment Period Written/Paper Submissions
be scheduled on February 25, 2016,
between approximately 1 p.m. and 2 AGENCY: Food and Drug Administration, Submit written/paper submissions as
p.m. and on February 26, 2016, between HHS. follows:
approximately 8:30 a.m. and 9:30 a.m. Notice; extension of the
ACTION: • Mail/Hand delivery/Courier (for
Those individuals interested in making comment period. written/paper submissions): Division of
formal oral presentations should notify Dockets Management (HFA–305), Food
the contact person and submit a brief SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers
statement of the general nature of the Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
evidence or arguments they wish to extending the comment period provided • For written/paper comments
present, the names and addresses of in the notice entitled ‘‘Over-the-Counter submitted to the Division of Dockets
proposed participants, and an Sunscreens: Safety and Effectiveness Management, FDA will post your
indication of the approximate time Data; Draft Guidance for Industry; comment, as well as any attachments,
requested to make their presentation on Availability’’ that appeared in the except for information submitted,
mstockstill on DSK4VPTVN1PROD with NOTICES6
or before February 9, 2016. Time Federal Register on November 23, 2015 marked and identified, as confidential,
allotted for each presentation may be (80 FR 72975). That notice announced if submitted as detailed in
limited. If the number of registrants the availability of a draft guidance for ‘‘Instructions.’’
requesting to speak is greater than can industry and requested comments to Instructions: All submissions received
be reasonably accommodated during the that draft guidance by January 22, 2016. must include the Docket No. FDA–
scheduled open public hearing session, FDA is extending the draft guidance’s 2015–D–4021 for ‘‘Over-the-Counter
FDA may conduct a lottery to determine comment period by 30 days (to February Sunscreens: Safety and Effectiveness
the speakers for the scheduled open 22, 2016) in response to a request for an Data; Draft Guidance for Industry.’’
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![Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices 941
Received comments will be placed in FOR FURTHER INFORMATION CONTACT: Individuals who plan to attend and
the docket and, except for those Kristen Hardin, Center for Drug need special assistance, such as sign
submitted as ‘‘Confidential Evaluation and Research, Food and language interpretation or other
Submissions,’’ publicly viewable at Drug Administration, 10903 New reasonable accommodations, should
http://www.regulations.gov or at the Hampshire Ave., Bldg. 22, Rm. 5443, notify the Contact Person listed below
Division of Dockets Management Silver Spring, MD 20993–0002, 240– in advance of the meeting.
between 9 a.m. and 4 p.m., Monday 402–4246. The meeting will be closed to the
through Friday. SUPPLEMENTARY INFORMATION: public in accordance with the
• Confidential Submissions—To provisions set forth in sections
I. Background 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
submit a comment with confidential
information that you do not wish to be In the Federal Register of November as amended. The grant applications
made publicly available, submit your 23, 2015 (80 FR 72975), FDA published and/or contract proposals and the
comments only as a written/paper a notice of availability with a 60-day discussions could disclose confidential
submission. You should submit two comment period for the draft guidance trade secrets or commercial property
copies total. One copy will include the for industry entitled ‘‘Over-the-Counter such as patentable material, and
information you claim to be confidential Sunscreens: Safety and Effectiveness personal information concerning
with a heading or cover note that states Data.’’ Publication of that draft guidance individuals associated with the grant
‘‘THIS DOCUMENT CONTAINS was mandated by the Sunscreen applications and/or contract proposals,
CONFIDENTIAL INFORMATION.’’ The Innovation Act (SIA), which also the disclosure of which would
Agency will review this copy, including requires FDA to publish the final constitute a clearly unwarranted
the claimed confidential information, in guidance no later than November 26, invasion of personal privacy.
its consideration of comments. The 2016. Name of Committee: National Advisory
second copy, which will have the The Agency has received a request for Mental Health Council.
claimed confidential information a 30-day extension of the comment Date: February 4, 2016.
redacted/blacked out, will be available period to provide more time for Closed: 8:00 a.m. to 9:00 a.m.
for public viewing and posted on http:// regulated industry to prepare a detailed Agenda: To review and evaluate the NIMH
and meaningful response to the draft Division of Intramural Research Programs.
www.regulations.gov. Submit both Place: National Institutes of Health,
copies to the Division of Dockets guidance. FDA has considered the
Neuroscience Center, Conference Rooms C/
Management. If you do not wish your request and is extending the comment D/E, 6001 Executive Boulevard, Rockville,
name and contact information to be period for 30 days, until February 22, MD 20852.
made publicly available, you can 2016. The Agency believes that a 30-day Open: 9:15 a.m. to 1:00 p.m.
provide this information on the cover extension will allow adequate time for Agenda: Presentation of the NIMH
sheet and not in the body of your interested persons to submit comments Director’s Report and discussion of NIMH
comments and you must identify this without compromising timely program and policy issues.
information as ‘‘confidential.’’ Any publication of the final guidance as Place: National Institutes of Health,
mandated by the SIA. Neuroscience Center, Conference Rooms C/
information marked as ‘‘confidential’’ D/E, 6001 Executive Boulevard, Rockville,
will not be disclosed except in II. Electronic Access MD 20852.
accordance with 21 CFR 10.20 and other Closed: 2:00 p.m. to 5:00 p.m.
applicable disclosure law. For more Persons with access to the Internet
may obtain the draft guidance at either Agenda: To review and evaluate grant
information about FDA’s posting of applications.
comments to public dockets, see 80 FR http://www.fda.gov/Drugs/ Place: National Institutes of Health,
56469, September 18, 2015, or access GuidanceCompliance Neuroscience Center, Conference Rooms C/
the information at: http://www.fda.gov/ RegulatoryInformation/Guidances/ D/E, 6001 Executive Boulevard, Rockville,
regulatoryinformation/dockets/ default.htm or http:// MD 20852.
default.htm. www.regulations.gov. Contact Person: Jean G. Noronha, Ph.D.,
Director, Division of Extramural Activities
Docket: For access to the docket to Dated: January 4, 2016.
National Institute of Mental Health, NIH
read background documents or the Leslie Kux, Neuroscience Center, 6001 Executive Blvd.,
electronic and written/paper comments Associate Commissioner for Policy. Room 6147, MSC 9609, Bethesda, MD 20892–
received, go to http:// [FR Doc. 2016–00128 Filed 1–7–16; 8:45 am] 9609, 301–443–3367, jnoronha@mail.nih.gov.
www.regulations.gov and insert the BILLING CODE 4164–01–P Any member of the public interested
docket number, found in brackets in the in presenting oral comments to the
heading of this document, into the committee may notify the Contact
‘‘Search’’ box and follow the prompts DEPARTMENT OF HEALTH AND Person listed on this notice at least 10
and/or go to the Division of Dockets HUMAN SERVICES days in advance of the meeting.
Management, 5630 Fishers Lane, Rm. Interested individuals and
1061, Rockville, MD 20852. National Institutes of Health representatives of organizations may
Submit written requests for single submit a letter of intent, a brief
copies of the draft guidance to the National Institute of Mental Health: description of the organization
Division of Drug Information, Center for Notice of Meeting represented, and a short description of
Drug Evaluation and Research, Food Pursuant to section 10(d) of the the oral presentation. Only one
mstockstill on DSK4VPTVN1PROD with NOTICES6
and Drug Administration, 10001 New Federal Advisory Committee Act, as representative of an organization may be
Hampshire Ave., Hillandale Building, amended (5 U.S.C. App.), notice is allowed to present oral comments and if
4th Floor, Silver Spring, MD 20993– hereby given of a meeting of the accepted by the committee,
0002. Send one self-addressed adhesive National Advisory Mental Health presentations may be limited to five
label to assist that office in processing Council. minutes. Both printed and electronic
your requests. See the SUPPLEMENTARY The meeting will be open to the copies are requested for the record. In
INFORMATION section for electronic public as indicated below, with addition, any interested person may file
access to the draft guidance document. attendance limited to space available. written comments with the committee
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Document Created: 2016-01-16 01:15:17
Document Modified: 2016-01-16 01:15:17
| 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; extension of the comment period. | |
| Dates | FDA is extending the comment period for the draft guidance by an additional 30 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by February 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 20993-0002, 240- 402-4246. | |
| FR Citation | 81 FR 940 |
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