82 FR 24722 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 102 (May 30, 2017)

Page Range		24722-24722
FR Document		2017-11011

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.

Federal Register, Volume 82 Issue 102 (Tuesday, May 30, 2017)

[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Page 24722]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11011]


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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, [email protected].

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 http://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

24722 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices

and written submissions submitted to If you require special accommodations ACTION: Notice.
the Docket (see the ADDRESSES section) due to a disability, please contact
on or before June 7, 2017, will be Lauren D. Tesh at least 7 days in SUMMARY: The Food and Drug
provided to the committee. Oral advance of the meeting. Administration (FDA) is publishing a
presentations from the public will be FDA is committed to the orderly list of information collections that have
scheduled between approximately 8:50 conduct of its advisory committee been approved by the Office of
a.m. to 9:10 a.m., 11 a.m. to 11:20 a.m., meetings. Please visit our Web site at Management and Budget (OMB) under
and 1:55 p.m. to 2:15 p.m. on June 21, https://www.fda.gov/ the Paperwork Reduction Act of 1995.
2017. Oral presentations from the public AdvisoryCommittees/AboutAdvisory
will also be scheduled between Committees/ucm111462.htm for FOR FURTHER INFORMATION CONTACT: Ila
approximately 8:50 a.m. to 9:10 a.m. procedures on public conduct during S. Mizrachi, Office of Operations, Food
and 11 a.m. to 11:20 a.m. on June 22, advisory committee meetings. and Drug Administration, Three White
2017. Those individuals interested in Notice of this meeting is given under Flint North, 11601 Landsdown St.,
making formal oral presentations should the Federal Advisory Committee Act (5 North Bethesda, MD 20852,
notify the contact person and submit a U.S.C. app. 2). 301–796–7726, PRAStaff@fda.hhs.gov.
brief statement of the general nature of Dated: May 23, 2017.
the evidence or arguments they wish to SUPPLEMENTARY INFORMATION: The
Anna K. Abram, following is a list of FDA information
present, the names and addresses of
proposed participants, and an Deputy Commissioner for Policy, Planning, collections recently approved by OMB
Legislation, and Analysis. under § 3507 of the Paperwork
indication of the approximate time
[FR Doc. 2017–11030 Filed 5–26–17; 8:45 am] Reduction Act of 1995 (44 U.S.C. 3507).
requested to make their presentation on
or before May 30, 2017. Time allotted BILLING CODE 4164–01–P The OMB control number and
for each presentation may be limited. If expiration date of OMB approval for
the number of registrants requesting to each information collection are shown
speak is greater than can be reasonably DEPARTMENT OF HEALTH AND
in table 1. Copies of the supporting
accommodated during the scheduled HUMAN SERVICES
statements for the information
open public hearing session, FDA may Food and Drug Administration collections are available on the Internet
conduct a lottery to determine the at http://www.reginfo.gov/public/do/
speakers for the scheduled open public [Docket Nos. FDA–2016–N–2544; FDA–
2013–N–0823; FDA–2013–N–0795; FDA–
PRAMain. An Agency may not conduct
hearing session. The contact person will or sponsor, and a person is not required
notify interested persons regarding their 2013–N–1147; FDA–2013–N–1064; FDA–
2008–D–0150; FDA–2013–N–0663; FDA– to respond to, a collection of
request to speak by May 31, 2017.
Persons attending FDA’s advisory 2010–D–0319; FDA–2013–N–0403; FDA– information unless it displays a
2012–D–0530; FDA–2016–N–0544] currently valid OMB control number.
committee meetings are advised that the
Agency is not responsible for providing Agency Information Collection
access to electrical outlets. Activities; Announcement of Office of
FDA welcomes the attendance of the Management and Budget Approvals
public at its advisory committee
meetings and will make every effort to AGENCY: Food and Drug Administration,
accommodate persons with disabilities. HHS.

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires

Current Good Manufacturing Practice; Quality System Regulation ........................................................................ 0910–0073 1/31/2020
Format and Content Requirements for Over-the-Counter Drug Product Labeling ................................................. 0910–0340 1/31/2020
Medical Devices; Third Party Review Under FDAMA ............................................................................................. 0910–0375 1/31/2020
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for
Food Safety and Applied Nutrition ....................................................................................................................... 0910–0541 1/31/2020
Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 .................................... 0910–0551 1/31/2020
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims ................................................ 0910–0670 1/31/2020
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety
Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans ......................................... 0910–0672 1/31/2020
GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information .................. 0910–0754 1/31/2020
Protection of Human Subjects: Informed Consent; Institutional Review Boards .................................................... 0910–0755 1/31/2020
Requests for Feedback on Medical Device Submissions ....................................................................................... 0910–0756 1/31/2020
National Direct-to-Consumer Advertising Survey .................................................................................................... 0910–0828 1/31/2020

Dated: May 23, 2017.
Anna K. Abram,
sradovich on DSK3GMQ082PROD with NOTICES

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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Document Created: 2018-11-08 08:55:47
Document Modified: 2018-11-08 08:55:47

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.
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, [email protected]
FR Citation		82 FR 24722

82 FR 24722 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 102 (May 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration