20406 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Notices 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 

395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: March 28, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–8011 Filed 4–3–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0288] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on 

Statistical Evaluation of Stability Data, 

VICH GL51; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry (#219) entitled ‘‘Draft Guidance 

for Industry on Statistical Evaluation of 

Stability Data, VICH GL51.’’ 

This draft guidance has been 

developed for veterinary use by the 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This draft VICH guidance document is 

intended to provide recommendations 

on how to use stability data generated 

in accordance with the principles 

detailed in the VICH guidance entitled 

‘‘Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products, GL3(R)’’ to propose a retest 

period or shelf life in a registration 

application. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments on the draft 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: Mai 

Huynh, Center for Veterinary Medicine, 

(HFV–142), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–276–8273, 

Mai.huynh@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (#219) 

entitled, ‘‘Draft Guidance for Industry 

on Statistical Evaluation of Stability 

Data, VICH GL51.’’ In recent years, 

many important initiatives have been 

undertaken by regulatory authorities 

and industry associations to promote 

the international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Approval of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, the 

European Medicines Evaluation Agency, 

the European Federation of Animal 

Health, the Committee on Veterinary 

Medicinal Products, FDA, the U.S. 

Department of Agriculture, the Animal 

Health Institute, the Japanese Veterinary 

Pharmaceutical Association, the 

Japanese Association of Veterinary 

Biologics, and the Japanese Ministry of 

Agriculture, Forestry, and Fisheries. 

Four observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

government of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, and one representative from the 

industry of Canada. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Draft Guidance on Statistical 

Evaluation of Stability Data 

The VICH Steering Committee held a 

meeting on November 14, 2011, and 

agreed that the draft guidance document 

entitled ‘‘Draft Guidance for Industry on 

Statistical Evaluation of Stability Data, 

VICH GL51’’ should be made available 

for public comment. This draft VICH 

guidance document is intended to 

provide recommendations on how to 

use stability data generated in 

accordance with the principles detailed 

in the VICH guidance entitled, 

‘‘Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products, GL3(R)’’ to propose a retest 

period or shelf life in a registration 

application. This draft guidance 

describes when and how extrapolation 

can be considered when proposing a 

retest period for a drug substance or a 

shelf life for a veterinary medicinal 

product that extends beyond the period 

covered by available data from the 

stability study under the long-term 

storage condition. 

This draft guidance addresses the 

evaluation of stability data that should 

be submitted in registration applications 

for new molecular entities and 

associated veterinary medicinal 

products. The draft guidance provides 

recommendations on establishing retest 

periods and shelf lives for drug 

substances and veterinary medicinal 

products intended for storage at or 

below ‘‘room temperature.’’ It covers 

stability studies using single- or multifactor designs and full or reduced 

designs. 

FDA and the VICH Expert Working 

Group will consider comments about 

the draft guidance document. 


emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Notices 20407 

III. Significance of Guidance 

This draft guidance, developed under 

the VICH process, has been revised to 

conform to FDA’s good guidance 

practices regulation (21 CFR 10.115). 

For example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ In addition, guidance 

documents must not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. 

The draft guidance, when finalized, 

will represent the Agency’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of applicable statutes and 

regulations. 

IV. Paperwork Reduction Act of 1995 

This draft 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 this draft guidance 

have been approved under OMB control 

number 0910–0032. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 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. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 29, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–8039 Filed 4–3–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5630–N–02] 

Rental Assistance Demonstration: 

Extension of Public Comment Period 

and Clarification of Demonstration 

Components 

AGENCY: Office of the Assistant 

Secretary for Public and Indian Housing 

and Office of the Assistant Secretary for 

Housing-Federal Housing 

Commissioner, HUD. 

ACTION: Notice. 

SUMMARY: On March 8, 2012, HUD 

published a notice in the Federal 

Register inviting public comments on 

the demonstration notice posted on 

HUD’s Web site entitled ‘‘Rental 

Assistance Demonstration—Partial 

Implementation and Request for 

Comments’’ (Program Notice). This 

notice extends the due date for the 

submission of comments on the Program 

Notice. In addition, HUD is taking this 

opportunity to clarify the scope of the 

demonstration that took effect on March 

8, 2012. 

DATES: Comment Due Date: The new 

date for the submission of comments on 

the Program Notice is April 23, 2012. 

Effective Date: The effective date 

announced in the March 8, 2012, notice 

is unchanged. The provisions regarding 

the conversion of Rent Supp and RAP 

properties under Section III of the 

Program Notice were effective on March 

8, 2012. The Moderate Rehabilitation 

(Mod Rehab) provisions detailed in 

Section II of the Program Notice are not 

in effect until HUD reviews the public 

comments and issues a notice in the 

Federal Register. 

ADDRESSES: Interested persons are 

invited to submit comments on 

applicable parts of the March 8, 2012, 

notice to the Regulations Division, 

Office of General Counsel, Department 

of Housing and Urban Development, 

451 7th Street SW., Room 10276, 

Washington, DC 20410–0500. All 

submissions and communications must 

refer to ‘‘Rental Assistance 

Demonstration: Notice of Web 

Availability and Request for Comments’’ 

docket number FR–5630–N–01. There 

are two methods for submitting public 

comments. 

1. Submission of Comments by Mail. 

Comments may be submitted by mail to 

the Regulations Division, Office of 

General Counsel, Department of 

Housing and Urban Development, 451 

7th Street SW., Room 10276, 

Washington, DC 20410–0500. 

2. Electronic Submission of 

Comments. Interested persons may 

submit comments electronically through 

the Federal eRulemaking Portal at 

www.regulations.gov. HUD strongly 

encourages commenters to submit 

comments electronically. Electronic 

submission of comments allows the 

commenter maximum time to prepare 

and submit a comment, ensures timely 

receipt by HUD, and enables HUD to 

make them immediately available to the 

public. Comments submitted 

electronically through the 

www.regulations.gov Web site can be 

viewed by other commenters and 

interested members of the public. 

Commenters should follow the 

instructions provided on that site to 

submit comments electronically. 

Note: To receive consideration as public 

comments, comments must be submitted 

through one of the two methods specified 

above. Again, all submissions must refer to 

the docket number and title of the rule. Also, 

to expedite review of public comments, it is 

recommended commenters should organize 

their comments by specific topical areas and 

section numbers and label those areas 

accordingly. 

No Facsimile Comments. Facsimile 

(FAX) comments are not acceptable. 

Public Inspection of Public 

Comments. All properly submitted 

comments and communications 

submitted to HUD will be available for 

public inspection and copying between 

8 a.m. and 5 p.m. weekdays at the above 

address. Due to security measures at the 

HUD Headquarters building, an advance 

appointment to review the public 

comments must be scheduled by calling 

the Regulations Division at 202–402– 

3055 (this is not a toll-free number). 

Individuals with speech or hearing 

impairments may access this number 

via TTY by calling the Federal Relay 

Service, toll-free, at 800–877–8339. 

Copies of all comments submitted are 

available for inspection and 

downloading at www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: To 

assure a timely response, please 

electronically direct requests for further 

information to this email address: 

rad@hud.gov. Written requests may also 

be directed to the following address: 

Office of Public and Indian Housing— 

RAD Program, Department of Housing 

and Urban Development, 451 7th Street 

SW., Room 2000; Washington, DC 

20410. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 8, 2012, at 77 FR 14029, 

HUD published in the Federal Register 

a notice announcing HUD’s Rental 

Assistance Demonstration (RAD) 

program, which provides the 


emcdonald on DSK29S0YB1PROD with NOTICES