Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 51424-51425 [2017-24121]
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51424
Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices
ANDA submissions, as well as the presubmission certification statement
(referenced in table 1), takes into
consideration that much of this content
is related to information already
gathered for the ANDA submission. We
invite comments on these estimates.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Pre-Submission of Facility Information ................................
Certification statement submitted with the ANDA ...............
1 There
Number of
responses per
respondent
220
198
Total annual
responses
1.25
1.25
275
248
Average
burden per
response
Total
hours
1.1
4
303
990
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: October 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24099 Filed 11–3–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–N–0258; FDA–
2010–N–0623; FDA–2007–N–0383; FDA–
2009–N–0360; FDA–2016–N–4620; FDA–
2013–N–1496; FDA–2007–N–0220; FDA–
2017–N–1848; FDA–2017–N–1066; FDA–
2015–D–3327; FDA–2011–D–0689]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Pmangrum on DSK3GDR082PROD with NOTICES
Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission to Information to a
Master File in Support of Petitions; and Electronic Submission Using FDA 3053 .............................................
Voluntary Cosmetic Registration Program ..............................................................................................................
Radioactive Drug Research Committees ................................................................................................................
FDA Safety Communication Readership Survey ....................................................................................................
Medical Devices; Reports for Corrections and Removals ......................................................................................
Generic FDA Rapid Response Surveys ..................................................................................................................
Guidance for Industry: Pharmacogenomic Data Submissions ................................................................................
Cosmetic Labeling Regulations ...............................................................................................................................
Annual Reporting for Custom Device Exemption ....................................................................................................
GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation .......................................................
DeNovo Classification Process (Evaluation of Automatic Class II Designation) ....................................................
Dated: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24121 Filed 11–3–17; 8:45 am]
BILLING CODE 4164–01–P
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0910–0016
0910–0027
0910–0053
0910–0341
0910–0359
0910–0500
0910–0557
0910–0599
0910–0767
0910–0843
0910–0844
Date
approval
expires
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
9/30/2020
Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0403]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substantiation for
Dietary Supplement Claims Made
Under the Federal Food, Drug, and
Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) and the guidance entitled
‘‘Guidance for Industry: Substantiation
for Dietary Supplement Claims Made
Under Section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 5, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 5,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 5, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
Pmangrum on DSK3GDR082PROD with NOTICES
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
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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 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–
2011–N–0403 for ‘‘Substantiation for
Dietary Supplement Claims Made Under
the Federal Food, Drug, and Cosmetic
Act.’’ Received comments, those filed in
a timely manner (see ADDRESSES), 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
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51425
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06NON1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51424-51425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24121]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-N-0258; FDA-2010-N-0623; FDA-2007-N-0383; FDA-
2009-N-0360; FDA-2016-N-4620; FDA-2013-N-1496; FDA-2007-N-0220; FDA-
2017-N-1848; FDA-2017-N-1066; FDA-2015-D-3327; FDA-2011-D-0689]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Submission of Petitions: Food Additive, 0910-0016 9/30/2020
Color Additive (Including Labeling),
Submission to Information to a Master
File in Support of Petitions; and
Electronic Submission Using FDA 3053...
Voluntary Cosmetic Registration Program. 0910-0027 9/30/2020
Radioactive Drug Research Committees.... 0910-0053 9/30/2020
FDA Safety Communication Readership 0910-0341 9/30/2020
Survey.................................
Medical Devices; Reports for Corrections 0910-0359 9/30/2020
and Removals...........................
Generic FDA Rapid Response Surveys...... 0910-0500 9/30/2020
Guidance for Industry: Pharmacogenomic 0910-0557 9/30/2020
Data Submissions.......................
Cosmetic Labeling Regulations........... 0910-0599 9/30/2020
Annual Reporting for Custom Device 0910-0767 9/30/2020
Exemption..............................
GFI: E6(R2) Good Clinical Practice; 0910-0843 9/30/2020
International Council for Harmonisation
DeNovo Classification Process 0910-0844 9/30/2020
(Evaluation of Automatic Class II
Designation)...........................
------------------------------------------------------------------------
Dated: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24121 Filed 11-3-17; 8:45 am]
BILLING CODE 4164-01-P
