80 FR 33522 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Allergen Labeling and Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

Page Range		33522-33522
FR Document		2015-14437

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

Federal Register, Volume 80 Issue 113 (Friday, June 12, 2015)

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Page 33522]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-14437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1030]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Food Allergen Labeling and Reporting

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 ``Food Allergen Labeling and
Reporting'' 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 30, 2015, the Agency submitted a
proposed collection of information entitled ``Food Allergen Labeling
and Reporting'' 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 0910-0792. The approval
expires on May 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: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14437 Filed 6-11-15; 8:45 am]
BILLING CODE 4164-01-P

33522 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices

Articles’’ to OMB for review and 305), Food and Drug Administration, V. Electronic Access
clearance under 44 U.S.C. 3507. An 5630 Fishers Lane, Rm. 1061, Rockville,
Persons with access to the Internet
Agency may not conduct or sponsor, MD 20852.
may obtain the guidance at either http://
and a person is not required to respond FOR FURTHER INFORMATION CONTACT:
www.fda.gov/AnimalVeterinary/
to, a collection of information unless it Lynne Boxer, Center for Veterinary GuidanceComplianceEnforcement/
displays a currently valid OMB control Medicine (HFV–114), Food and Drug GuidanceforIndustry/default.htm or
number. OMB has now approved the Administration, 7500 Standish Pl., http://www.regulations.gov.
information collection and has assigned Rockville, MD 20855, 240–402–0611,
OMB control number 0910–0575. The lynne.boxer@fda.hhs.gov. Dated: June 8, 2015.
approval expires on May 31, 2018. A Leslie Kux,
SUPPLEMENTARY INFORMATION:
copy of the supporting statement for this Associate Commissioner for Policy.
information collection is available on I. Background [FR Doc. 2015–14360 Filed 6–11–15; 8:45 am]
the Internet at http://www.reginfo.gov/ In the Federal Register of August 1, BILLING CODE 4164–01–P
public/do/PRAMain. 2014 (79 FR 44803), FDA published the
Dated: June 9, 2015. notice of availability for a draft guidance
Leslie Kux, for industry #218 entitled ‘‘Cell-Based DEPARTMENT OF HEALTH AND
Associate Commissioner for Policy. Products for Animal Use’’ giving HUMAN SERVICES
interested persons until September 30,
[FR Doc. 2015–14436 Filed 6–11–15; 8:45 am] Food and Drug Administration
2014, to comment on the draft guidance.
BILLING CODE P
FDA received several comments on the
draft guidance and those comments [Docket No. FDA–2014–N–1030]
DEPARTMENT OF HEALTH AND were considered as the guidance was
finalized. Editorial changes were made Agency Information Collection
HUMAN SERVICES Activities; Announcement of Office of
to improve clarity. The guidance
Food and Drug Administration announced in this notice finalizes the Management and Budget Approval;
draft guidance dated August 1, 2014. Food Allergen Labeling and Reporting
[Docket No. FDA–2014–D–0634]
II. Significance of Guidance AGENCY: Food and Drug Administration,
Cell-Based Products for Animal Use; This level 1 guidance is being issued HHS.
Guidance for Industry; Availability consistent with FDA’s good guidance ACTION: Notice.
AGENCY: Food and Drug Administration, practices regulation (21 CFR 10.115).
HHS. The guidance represents the current SUMMARY: The Food and Drug
thinking of FDA on Cell-Based Products Administration (FDA) is announcing
ACTION: Notice.
for Animal Use. It does not establish any that a collection of information entitled
SUMMARY: The Food and Drug rights for any person and is not binding ‘‘Food Allergen Labeling and Reporting’’
Administration (FDA) is announcing the on FDA or the public. You can use an has been approved by the Office of
availability of a guidance for industry alternative approach if it satisfies the Management and Budget (OMB) under
#218 (GFI #218) entitled ‘‘Cell-Based requirements of the applicable statutes the Paperwork Reduction Act of 1995.
Products for Animal Use.’’ FDA is aware and regulations. FOR FURTHER INFORMATION CONTACT: FDA
that many potential veterinary therapies III. Paperwork Reduction Act of 1995 PRA Staff, Office of Operations, Food
may be produced using cell-based and Drug Administration, 8455
products. GFI #218 describes FDA’s This guidance refers to previously
Colesville Rd., COLE–14526, Silver
Center for Veterinary Medicine’s current approved collections of information
Spring, MD 20993–0002, PRAStaff@
thinking on cell-based products for found in FDA regulations. These
fda.hhs.gov.
animal use that meet the definition of a collections of information are subject to
new animal drug. This guidance is for review by the Office of Management and SUPPLEMENTARY INFORMATION: On March
persons developing, manufacturing, or Budget (OMB) under the Paperwork 30, 2015, the Agency submitted a
marketing cell-based products, Reduction Act of 1995 (44 U.S.C. 3501– proposed collection of information
including ‘‘animal stem cell-based 3520). The collections of information in entitled ‘‘Food Allergen Labeling and
products’’. 21 CFR part 514 and 21 CFR 511.1 have Reporting’’ to OMB for review and
been approved under OMB control clearance under 44 U.S.C. 3507. An
DATES: Submit either electronic or numbers 0910–0032 and 0910–0117, Agency may not conduct or sponsor,
written comments on Agency guidances respectively. and a person is not required to respond
at any time. to, a collection of information unless it
ADDRESSES: Submit written requests for IV. Comments
displays a currently valid OMB control
single copies of the guidance to the Interested persons may submit either number. OMB has now approved the
Policy and Regulations Staff (HFV–6), electronic comments regarding this information collection and has assigned
Center for Veterinary Medicine, Food document to http://www.regulations.gov OMB control number 0910–0792. The
and Drug Administration, 7519 Standish or written comments to the Division of approval expires on May 31, 2018. A
Pl., Rockville, MD 20855. Send one self- Dockets Management (see ADDRESSES). It copy of the supporting statement for this
addressed adhesive label to assist that is only necessary to send one set of information collection is available on
mstockstill on DSK4VPTVN1PROD with NOTICES

office in processing your requests. See comments. Identify comments with the the Internet at http://www.reginfo.gov/
the SUPPLEMENTARY INFORMATION section docket number found in brackets in the public/do/PRAMain.
for electronic access to the guidance heading of this document. Received
comments may be seen in the Division Dated: June 9, 2015.
document.
Submit electronic comments on the of Dockets Management between 9 a.m. Leslie Kux,
guidance to http://www.regulations.gov. and 4 p.m., Monday through Friday, and Associate Commissioner for Policy.
Submit written comments to the will be posted to the docket at http:// [FR Doc. 2015–14437 Filed 6–11–15; 8:45 am]
Division of Dockets Management (HFA– www.regulations.gov. BILLING CODE 4164–01–P

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Document Created: 2018-02-22 10:15:58
Document Modified: 2018-02-22 10:15:58

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 33522

80 FR 33522 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Allergen Labeling and Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration