Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices for Finished Pharmaceuticals, 32136 [2015-13696]

Download as PDF 32136 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food and Drug Administration [Docket No. FDA–2011–N–0362] [Docket No. FDA–2014–N–1069] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices for Finished Pharmaceuticals Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Blood Establishment Registration and Product Listing, Form FDA 2830 [Docket No. FDA–2011–N–0144] AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Food and Drug Administration, HHS. Notice. ACTION: Notice. ACTION: SUMMARY: 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. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: On March 06, 2015, the Agency submitted a proposed collection of information entitled ‘‘Current Good Manufacturing Practices for Finished Pharmaceuticals’’ 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 0910–0139. The approval expires on May 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: Dated: June 1, 2015. Leslie Kux, Associate Commissioner for Policy. Dated: June 1, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13696 Filed 6–4–15; 8:45 am] [FR Doc. 2015–13697 Filed 6–4–15; 8:45 am] BILLING CODE 4164–01–P asabaliauskas on DSK5VPTVN1PROD with NOTICES The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Current Good Manufacturing Practices for Finished Pharmaceuticals’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. BILLING CODE 4164–01–P 18:31 Jun 04, 2015 Jkt 235001 The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Blood Establishment Registration and Product Listing, Form FDA 2830’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. On February 09, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Blood Establishment Registration and Product Listing, Form FDA 2830’’ 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 0910–0052. The approval expires on May 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. PO 00000 AGENCY: Food and Drug Administration, HHS. SUMMARY: VerDate Sep<11>2014 Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business; Availability Frm 00055 Fmt 4703 Sfmt 4703 Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility. We are issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Although you may comment on any guidance at any time (21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, submit either electronic or written comments on the draft guidance by August 19, 2015. Submit either electronic or written comments on the proposed collection of information by August 4, 2015. ADDRESSES: Submit written requests for single copies of this draft guidance to the Office of Enforcement and Import Operations (ELEM–3108), Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance, including comments SUMMARY: E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Page 32136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13696]



[[Page 32136]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0362]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Current Good Manufacturing Practices 
for Finished Pharmaceuticals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Current Good Manufacturing 
Practices for Finished Pharmaceuticals'' 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 March 06, 2015, the Agency submitted a 
proposed collection of information entitled ``Current Good 
Manufacturing Practices for Finished Pharmaceuticals'' 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 0910-0139. The approval expires on May 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.

    Dated: June 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13696 Filed 6-4-15; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.