81 FR 41544 - Special Protocol Assessment; Draft Guidance for Industry; Extension of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 123 (June 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 123 (June 27, 2016)
| Page Range | 41544-41544 | |
| FR Document | 2016-15106 |
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)] [Notices] [Page 41544] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15106] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1174] Special Protocol Assessment; Draft Guidance for Industry; Extension of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability, published in the Federal Register of May 4, 2016 (81 FR 26799), announcing the draft guidance for industry entitled ``Special Protocol Assessment.'' We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016. DATES: Submit either electronic or written comments by July 19, 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-2016-D-1174 for ``Special Protocol Assessment; 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. FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: In the Federal Register of May 4, 2016 (81 FR 26799), FDA published a notice of availability. Interested persons were originally given until July 5, 2016, to comment on the draft guidance for industry entitled ``Special Protocol Assessment.'' From July 1 through July 5, 2016, the Federal eRulemaking Portal, http://www.regulations.gov, is undergoing maintenance. We are, therefore, extending the comment period for the draft guidance for industry entitled ``Special Protocol Assessment.'' The extended comment period will close on July 19, 2016. Dated: June 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15106 Filed 6-24-16; 8:45 am] BILLING CODE 4164-01-P
![41544 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices
Planning, Research and Evaluation, 330 the docket unchanged. Because your www.regulations.gov. Submit both
C Street SW., Washington, DC 20201. comment will be made public, you are copies to the Division of Dockets
Attention Reports Clearance Officer. All solely responsible for ensuring that your Management. If you do not wish your
requests should be identified by the title comment does not include any name and contact information to be
of the information collection. Email confidential information that you or a made publicly available, you can
address: infocollection@acf.hhs.gov. third party may not wish to be posted, provide this information on the cover
OMB Comment: OMB is required to such as medical information, your or sheet and not in the body of your
make a decision concerning the anyone else’s Social Security number, or comments and you must identify this
collection of information between 30 confidential business information, such information as ‘‘confidential.’’ Any
and 60 days after publication of this as a manufacturing process. Please note information marked as ‘‘confidential’’
document in the Federal Register. that if you include your name, contact will not be disclosed except in
Therefore, a comment is best assured of information, or other information that accordance with 21 CFR 10.20 and other
having its full effect if OMB receives it identifies you in the body of your
applicable disclosure law. For more
within 30 days of publication. Written comments, that information will be
information about FDA’s posting of
comments and recommendations for the posted on http://www.regulations.gov.
• If you want to submit a comment comments to public dockets, see 80 FR
proposed information collection should 56469, September 18, 2015, or access
be sent directly to the following: Office with confidential information that you
do not wish to be made available to the the information at: http://www.fda.gov/
of Management and Budget, Paperwork
public, submit the comment as a regulatoryinformation/dockets/
Reduction Project, Email: OIRA_
written/paper submission and in the default.htm.
SUBMISSION@OMB.EOP.GOV Attn:
Desk Officer for the Administration for manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Children and Families. Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Robert Sargis, received, go to http://
Reports Clearance Officer. Submit written/paper submissions as www.regulations.gov and insert the
[FR Doc. 2016–15046 Filed 6–24–16; 8:45 am] follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
BILLING CODE 4184–01–P heading of this document, into the
written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
DEPARTMENT OF HEALTH AND and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
HUMAN SERVICES Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 1061, Rockville, MD 20852.
Food and Drug Administration submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Management, FDA will post your Amalia Himaya, Center for Drug
[Docket No. FDA–2016–D–1174]
comment, as well as any attachments, Evaluation and Research, Food and
Special Protocol Assessment; Draft except for information submitted, Drug Administration, 10903 New
Guidance for Industry; Extension of marked and identified, as confidential, Hampshire Ave., Bldg. 22, Rm. 6439,
the Comment Period if submitted as detailed in Silver Spring, MD 20993–0002, 301–
‘‘Instructions.’’ 796–0700; or Stephen Ripley, Center for
AGENCY: Food and Drug Administration, Instructions: All submissions received Biologics Evaluation and Research,
HHS. must include the Docket No. FDA– Food and Drug Administration, 10903
Notice; extension of the
ACTION: 2016–D–1174 for ‘‘Special Protocol New Hampshire Ave., Bldg. 71, Rm.
comment period. Assessment; Draft Guidance for 3128, Silver Spring, MD 20993–0002,
Industry.’’ Received comments will be
SUMMARY: The Food and Drug 240–402–7911.
placed in the docket and, except for
Administration (FDA or we) is those submitted as ‘‘Confidential SUPPLEMENTARY INFORMATION: In the
extending the comment period for the Submissions,’’ publicly viewable at Federal Register of May 4, 2016 (81 FR
notice of availability, published in the http://www.regulations.gov or at the 26799), FDA published a notice of
Federal Register of May 4, 2016 (81 FR Division of Dockets Management availability.
26799), announcing the draft guidance between 9 a.m. and 4 p.m., Monday
for industry entitled ‘‘Special Protocol Interested persons were originally
through Friday. given until July 5, 2016, to comment on
Assessment.’’ We are taking this action • Confidential Submissions—To
due to maintenance on the Federal the draft guidance for industry entitled
submit a comment with confidential
eRulemaking portal from July 1 through ‘‘Special Protocol Assessment.’’
information that you do not wish to be
July 5, 2016. made publicly available, submit your From July 1 through July 5, 2016, the
DATES: Submit either electronic or comments only as a written/paper Federal eRulemaking Portal, http://
written comments by July 19, 2016. submission. You should submit two www.regulations.gov, is undergoing
ADDRESSES: You may submit comments copies total. One copy will include the maintenance. We are, therefore,
as follows: information you claim to be confidential extending the comment period for the
with a heading or cover note that states draft guidance for industry entitled
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS ‘‘Special Protocol Assessment.’’ The
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The extended comment period will close on
mstockstill on DSK3G9T082PROD with NOTICES
following way: Agency will review this copy, including July 19, 2016.
• Federal eRulemaking Portal: http:// the claimed confidential information, in Dated: June 21, 2016.
www.regulations.gov. Follow the its consideration of comments. The
Leslie Kux,
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information Associate Commissioner for Policy.
including attachments, to http:// redacted/blacked out, will be available [FR Doc. 2016–15106 Filed 6–24–16; 8:45 am]
www.regulations.gov will be posted to for public viewing and posted on http:// BILLING CODE 4164–01–P
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Document Created: 2016-06-25 02:06:47
Document Modified: 2016-06-25 02:06:47
| 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 | Submit either electronic or written comments by July 19, 2016. | |
| Contact | Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 41544 |
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