Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 24722 [2017-11011]
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24722
Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
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ACTION:
Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–11030 Filed 5–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–N–2544; FDA–
2013–N–0823; FDA–2013–N–0795; FDA–
2013–N–1147; FDA–2013–N–1064; FDA–
2008–D–0150; FDA–2013–N–0663; FDA–
2010–D–0319; FDA–2013–N–0403; FDA–
2012–D–0530; FDA–2016–N–0544]
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, 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 § 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.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
sradovich on DSK3GMQ082PROD with NOTICES
Current Good Manufacturing Practice; Quality System Regulation ........................................................................
Format and Content Requirements for Over-the-Counter Drug Product Labeling .................................................
Medical Devices; Third Party Review Under FDAMA .............................................................................................
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for
Food Safety and Applied Nutrition .......................................................................................................................
Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 ....................................
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims ................................................
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety
Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans .........................................
GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information ..................
Protection of Human Subjects: Informed Consent; Institutional Review Boards ....................................................
Requests for Feedback on Medical Device Submissions .......................................................................................
National Direct-to-Consumer Advertising Survey ....................................................................................................
Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11011 Filed 5–26–17; 8:45 am]
BILLING CODE 4164–01–P
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Date approval
expires
0910–0073
0910–0340
0910–0375
1/31/2020
1/31/2020
1/31/2020
0910–0541
0910–0551
0910–0670
1/31/2020
1/31/2020
1/31/2020
0910–0672
0910–0754
0910–0755
0910–0756
0910–0828
1/31/2020
1/31/2020
1/31/2020
1/31/2020
1/31/2020
]]>Agencies
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Page 24722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11011]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2016-N-2544; FDA-2013-N-0823; FDA-2013-N-0795; FDA-
2013-N-1147; FDA-2013-N-1064; FDA-2008-D-0150; FDA-2013-N-0663; FDA-
2010-D-0319; FDA-2013-N-0403; FDA-2012-D-0530; FDA-2016-N-0544]
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, 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 Sec. 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
------------------------------------------------------------------------
Current Good Manufacturing Practice; 0910-0073 1/31/2020
Quality System Regulation..............
Format and Content Requirements for Over- 0910-0340 1/31/2020
the-Counter Drug Product Labeling......
Medical Devices; Third Party Review 0910-0375 1/31/2020
Under FDAMA............................
Preparing a Claim of Categorical 0910-0541 1/31/2020
Exclusion or an Environmental
Assessment for Submission to the Center
for Food Safety and Applied Nutrition..
Application for Participation in the 0910-0551 1/31/2020
Medical Device Fellowship Program; Form
FDA 3608...............................
GFI: Hypertension Indication; Drug 0910-0670 1/31/2020
Labeling for Cardiovascular Outcome
Claims.................................
Investigational New Drug Safety 0910-0672 1/31/2020
Reporting Requirements for Human Drug
and Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans......................
GFI: Dear Health Care Provider Letters; 0910-0754 1/31/2020
Improving Communication of Important
Safety Information.....................
Protection of Human Subjects: Informed 0910-0755 1/31/2020
Consent; Institutional Review Boards...
Requests for Feedback on Medical Device 0910-0756 1/31/2020
Submissions............................
National Direct-to-Consumer Advertising 0910-0828 1/31/2020
Survey.................................
------------------------------------------------------------------------
Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11011 Filed 5-26-17; 8:45 am]
BILLING CODE 4164-01-P
