80 FR 52766 - Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 169 (September 1, 2015)

Page Range		52766-52767
FR Document		2015-21583

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #227 entitled ``Two- Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions to the Center of Veterinary Medicine (CVM) to support approval of a new animal drug or abbreviated new animal drug.

Federal Register, Volume 80 Issue 169 (Tuesday, September 1, 2015)

[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52766-52767]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-21583]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1492]

Two-Phased Chemistry, Manufacturing, and Controls Technical
Sections; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (GFI) #227 entitled ``Two-
Phased Chemistry, Manufacturing, and Controls (CMC) Technical
Sections.'' The guidance provides recommendations to sponsors
submitting chemistry, manufacturing, and controls (CMC) data
submissions to the Center of Veterinary Medicine (CVM) to support
approval of a new animal drug or abbreviated new animal drug.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather Longstaff, Center for
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0651,
heather.longstaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20, 2014 (79 FR 62635) FDA
published the notice of availability for a draft guidance for industry
#227 entitled ``Two-Phased Chemistry, Manufacturing, and Controls (CMC)
Technical Sections'' giving interested persons until December 19, 2014,
to comment on the draft guidance. FDA received one comment on the draft
guidance and that comment was considered as the guidance was finalized.
The guidance announced in this notice finalizes the draft guidance
dated October 2014.
GFI #227 provides recommendations to sponsors submitting CMC data
submissions to CVM to support approval of a new animal drug or
abbreviated new animal drug. The two-phased process allows for two
separate CMC submissions, each with its own review clock, and each
including complete appropriate CMC information that is available for
review at the time of submission. The guidance specifies the technical
details of how the process works, the review clocks, the information
that is appropriate for each technical section submission, and the
possible review outcomes. The guidance also includes CVM's
recommendations for meetings between the Division of Manufacturing
Technologies and the sponsor during this process to ensure concurrence
with the approach used for the CMC technical section.

[[Page 52767]]

II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good
guidance practices regulations (21 CFR 10.115). This guidance
represents the current thinking of FDA on two-phased CMC technical
sections. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 and section 512(n)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have
been approved under OMB control numbers 0910-0032 and 0910-0669,
respectively.

IV. Comments

Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

Dated: August 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21583 Filed 8-31-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52767

II. Significance of Guidance DEPARTMENT OF HEALTH AND strong partnership with state and
HUMAN SERVICES territorial offices is a key to continue
This level 1 guidance is being issued progress toward eliminating health
consistent with FDA’s good guidance Office of the Secretary disparities. To best facilitate continued
practices regulations (21 CFR 10.115). partnerships, OMH needs information
This guidance represents the current [Document Identifier: HHS–OS–0990–New–
30D] about the current activities, challenges,
thinking of FDA on two-phased CMC
and resources within state and
technical sections. It does not establish Agency Information Collection territorial offices of minority health. The
any rights for any person and is not Activities; Submission to OMB for State and Territorial Health Disparities
binding on FDA or the public. You can Review and Approval; Public Comment Survey is intended to support OMH
use an alternative approach if it satisfies Request informational needs by collecting,
the requirements of the applicable
AGENCY: Office of the Secretary, HHS. organizing, and presenting a variety of
statutes and regulations.
information about states and U.S.
ACTION: Notice.
III. Paperwork Reduction Act of 1995 territories, including the current status
SUMMARY: In compliance with section of minority health and health
This guidance refers to previously
3507(a)(1)(D) of the Paperwork disparities, the organization and
approved collections of information
Reduction Act of 1995, the Office of the operation of state and territorial offices
found in FDA regulations. These
Secretary (OS), Department of Health of minority health, and state/territorial
collections of information are subject to
and Human Services, has submitted an implementation of federal standards and
review by the Office of Management and
Information Collection Request (ICR), evidence-based practices designed to
Budget (OMB) under the Paperwork
described below, to the Office of address disparities and improve
Reduction Act of 1995 (44 U.S.C. 3501–
Management and Budget (OMB) for minority health. The STHD Survey,
3520). The collections of information in
review and approval. The ICR is for a which will focus on the activities,
21 CFR part 514 and section 512(n)(1)
new collection. Comments submitted staffing, and funding of State Minority
of the Federal Food, Drug, and Cosmetic
during the first public review of this ICR Health Entities, is part of a larger project
Act (21 U.S.C. 360b(n)(1)) have been
will be provided to OMB. OMB will to catalog the extent of health disparities
approved under OMB control numbers
accept further comments from the and the activities underway to reduce
0910–0032 and 0910–0669, respectively.
public on this ICR during the review them in each state and U.S. territory.
IV. Comments and approval period. The STHD Survey supports OMH’s
DATES: Comments on the ICR must be goals of working with states and
Interested persons may submit either
received on or before October 1, 2015. territories to improve the health of racial
electronic comments regarding this
ADDRESSES: Submit your comments to and ethnic minority populations and
document to http://www.regulations.gov
OIRA_submission@omb.eop.gov or via eliminate health disparities. While
or written comments to the Division of
facsimile to (202) 395–5806. existing, state/territorial-specific
Dockets Management (see ADDRESSES). It
FOR FURTHER INFORMATION CONTACT: information sources (e.g., quantitative
is only necessary to send one set of
Information Collection Clearance staff, data points available from the Agency
comments. Identify comments with the
Information.CollectionClearance@ for Healthcare Research and Quality’s
docket number found in brackets in the
hhs.gov or (202) 690–6162. National Healthcare Disparities Report
heading of this document. Received
State Snapshots) offer important facts
comments may be seen in the Division SUPPLEMENTARY INFORMATION: When
about the status of health disparities,
of Dockets Management between 9 a.m. submitting comments or requesting
they do not provide context around the
and 4 p.m., Monday through Friday, and information, please include the
efforts underway to reduce them.
will be posted to the docket at http:// Information Collection Request Title
www.regulations.gov. and document identifier HHS–OS– Likely Respondents- Data will be
0990–New–30D for reference. collected using semi-structured
V. Electronic Access Information Collection Request Title: telephone interviews with state/
Persons with access to the Internet State and Territorial Health Disparities territorial minority health entity
may obtain the guidance at either Survey Abstract: The Office of Minority directors (or their designees) in
http://www.fda.gov/AnimalVeterinary/ Health (OMH), Office of the Secretary approximately 54 states and territories
GuidanceComplianceEnforcement/ (OS) is requesting approval from the (50 states plus the District of Columbia
GuidanceforIndustry/default.htm or Office of Management and Budget and the U.S. territories of Guam, Puerto
http://www.regulations.gov. (OMB) for a new data collection activity Rico, and the U.S. Virgin Islands). The
for the State and Territorial Health purpose of this interview is to collect
Dated: August 26, 2015. qualitative information about state/
Disparities Survey (STHD Survey).
Leslie Kux, OMH has a long history of territory program goals and activities,
Associate Commissioner for Policy. collaborating with states to improve partnerships, and organizational
[FR Doc. 2015–21583 Filed 8–31–15; 8:45 am] minority health outcomes and reduce structure, as well as quantitative data
BILLING CODE 4164–01–P health and health care disparities. A elements on staffing and funding.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
mstockstill on DSK4VPTVN1PROD with NOTICES

Number of
Number of Average hours Total burden
Form name responses per
respondents per response hours
respondents

State and Territorial Survey ............................................................................. 54 1 1.5 81

Total .......................................................................................................... ........................ ........................ ........................ 81

VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1

Document Created: 2018-02-26 10:04:59
Document Modified: 2018-02-26 10:04:59

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.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Heather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0651, [email protected]
FR Citation		80 FR 52766

80 FR 52766 - Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 169 (September 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration