80 FR 27694 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Recall Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 93 (May 14, 2015)

Page Range		27694-27694
FR Document		2015-11624

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``FDA Recall Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 93 (Thursday, May 14, 2015)

[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Notices]
[Page 27694]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1031]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; FDA Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``FDA Recall Regulations'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On February 27, 2015, the Agency submitted a 
proposed collection of information entitled, ``FDA Recall Regulations'' 
to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has 
assigned OMB control number 0910-0249. The approval expires on March 
31, 2018. A copy of the supporting statement for this information 
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11624 Filed 5-13-15; 8:45 am]
BILLING CODE 4164-01-P

27694 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices

TABLE 1—ESTIMATED REPORTING BURDEN 1—Continued
Surveys of pharmacists and patients on variations in the Number of Average
Number of Total annual Total
physical characteristics of generic drug pills and patients’ responses per burden per
respondents responses Hours
perceptions respondent response

Survey of patients #2 ........................................................... 1,000 1 1,000 0.3 300
(18 minutes)

Total .............................................................................. ........................ ........................ ........................ ........................ 1,017
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Eligibility is determined prior to mailing the surveys; screening is not required.

References SUPPLEMENTARY INFORMATION: On and Drug Administration, 8455
The following references have been February 27, 2015, the Agency Colesville Rd., COLE–14526, Silver
placed on display in the Division of submitted a proposed collection of Spring, MD 20993–0002, PRAStaff@
information entitled, ‘‘FDA Recall fda.hhs.gov.
Dockets Management (see ADDRESSES)
and may be seen by interested persons Regulations’’ to OMB for review and SUPPLEMENTARY INFORMATION: On
between 9 a.m. and 4 p.m., Monday clearance under 44 U.S.C. 3507. An January 8, 2015, the Agency submitted
through Friday, and are available Agency may not conduct or sponsor, a proposed collection of information
electronically at http:// and a person is not required to respond entitled, ‘‘Guidance for Industry: Formal
www.regulations.gov. to, a collection of information unless it Dispute Resolution; Scientific and
displays a currently valid OMB control Technical Issues Related to
1. Woodward, C.A., ‘‘Questionnaire number. OMB has now approved the
Construction and Question Writing for Pharmaceutical Current Good
information collection and has assigned Manufacturing Practice’’ to OMB for
Research in Medical Education,’’
Medical Education, 22, pp. 345–363
OMB control number 0910–0249. The review and clearance under 44 U.S.C.
(1988). approval expires on March 31, 2018. A 3507. An Agency may not conduct or
2. Fitzpatrick, R., ‘‘Surveys of Patient copy of the supporting statement for this sponsor, and a person is not required to
Satisfaction: II—Designing a information collection is available on respond to, a collection of information
Questionnaire and Conducting a the Internet at http://www.reginfo.gov/ unless it displays a currently valid OMB
Survey,’’ British Medical Journal, public/do/PRAMain. control number. OMB has now
302(6785), pp. 1129–1132 (1991).
Dated: May 8, 2015. approved the information collection and
Dated: May 8, 2015. Leslie Kux, has assigned OMB control number
Leslie Kux, Associate Commissioner for Policy. 0910–0563. The approval expires on
Associate Commissioner for Policy. [FR Doc. 2015–11624 Filed 5–13–15; 8:45 am] April 30, 2018. A copy of the supporting
[FR Doc. 2015–11623 Filed 5–13–15; 8:45 am] BILLING CODE 4164–01–P
statement for this information collection
is available on the Internet at http://
BILLING CODE 4164–01–P
www.reginfo.gov/public/do/PRAMain.
DEPARTMENT OF HEALTH AND Dated: May 8, 2015.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Leslie Kux,
HUMAN SERVICES Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–11609 Filed 5–13–15; 8:45 am]
Food and Drug Administration [Docket No. FDA–2014–N–1076] BILLING CODE 4164–01–P

[Docket No. FDA–2014–N–1031] Agency Information Collection
Activities; Announcement of Office of DEPARTMENT OF HOMELAND
Agency Information Collection Management and Budget Approval; SECURITY
Activities; Announcement of Office of Guidance for Industry: Formal Dispute
Management and Budget Approval; Resolution; Scientific and Technical U.S. Customs and Border Protection
FDA Recall Regulations Issues Related to Pharmaceutical
Current Good Manufacturing Practice [Docket No. USCBP–2015–0020]
AGENCY: Food and Drug Administration,
HHS. AGENCY: Food and Drug Administration, The U.S. Customs and Border
ACTION: Notice. HHS. Protection Airport and Seaport
ACTION: Notice. Inspections User Fee Advisory
SUMMARY: The Food and Drug Committee (UFAC)
Administration (FDA) is announcing SUMMARY: The Food and Drug AGENCY: U.S. Customs and Border
that a collection of information entitled, Administration (FDA) is announcing Protection, Department of Homeland
‘‘FDA Recall Regulations’’ has been that a collection of information entitled, Security (DHS).
approved by the Office of Management ‘‘Guidance for Industry: Formal Dispute
ACTION: Committee Management; Notice
and Budget (OMB) under the Paperwork Resolution; Scientific and Technical
Reduction Act of 1995. Issues Related to Pharmaceutical of Federal Advisory Public Committee
tkelley on DSK3SPTVN1PROD with NOTICES

Current Good Manufacturing Practice’’ Meeting.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food has been approved by the Office of SUMMARY: The U.S. Customs and Border
and Drug Administration, 8455 Management and Budget (OMB) under Protection Airport and Seaport
Colesville Rd., COLE–14526, Silver the Paperwork Reduction Act of 1995. Inspections User Fee Advisory
Spring, MD 20993–0002, PRAStaff@ FOR FURTHER INFORMATION CONTACT: FDA Committee (UFAC) will meet on
fda.hhs.gov. PRA Staff, Office of Operations, Food Tuesday, June 2, 2015, in Washington,

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Document Created: 2015-12-15 15:32:47
Document Modified: 2015-12-15 15:32:47

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		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 27694

80 FR 27694 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Recall Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 93 (May 14, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration