Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice, 27694 [2015-11609]

Download as PDF 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 physical characteristics of generic drug pills and patients’ perceptions Number of respondents Number of responses per respondent Average burden per response Total annual responses Total Hours Survey of patients #2 ........................................................... 1,000 1 1,000 0.3 (18 minutes) 300 Total .............................................................................. ........................ ........................ ........................ ........................ 1,017 1 There are no capital costs or operating and maintenance costs associated with this collection of information. is determined prior to mailing the surveys; screening is not required. 2 Eligibility References 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 https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at https:// www.regulations.gov. 1. Woodward, C.A., ‘‘Questionnaire Construction and Question Writing for Research in Medical Education,’’ Medical Education, 22, pp. 345–363 (1988). 2. Fitzpatrick, R., ‘‘Surveys of Patient Satisfaction: II—Designing a Questionnaire and Conducting a Survey,’’ British Medical Journal, 302(6785), pp. 1129–1132 (1991). Dated: May 8, 2015. Leslie Kux, Associate Commissioner for Policy. Dated: May 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11624 Filed 5–13–15; 8:45 am] [FR Doc. 2015–11623 Filed 5–13–15; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2014–N–1076] [Docket No. FDA–2014–N–1031] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: 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. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice’’ 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 SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Dated: May 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11609 Filed 5–13–15; 8:45 am] BILLING CODE 4164–01–P HHS. Notice. and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On January 8, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice’’ 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 0910–0563. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [Docket No. USCBP–2015–0020] The U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee (UFAC) U.S. Customs and Border Protection, Department of Homeland Security (DHS). ACTION: Committee Management; Notice of Federal Advisory Public Committee Meeting. AGENCY: The U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee (UFAC) will meet on Tuesday, June 2, 2015, in Washington, SUMMARY: E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Notices]
[Page 27694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1076]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry: Formal 
Dispute Resolution; Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Guidance for Industry: Formal 
Dispute Resolution; Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice'' 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 January 8, 2015, the Agency submitted a 
proposed collection of information entitled, ``Guidance for Industry: 
Formal Dispute Resolution; Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice'' 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 0910-0563. The approval expires on April 30, 2018. A 
copy of the supporting statement for this information collection is 
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11609 Filed 5-13-15; 8:45 am]
BILLING CODE 4164-01-P
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