12490 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Ann A. Jerkins, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 759, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–2242, 

jerkinsa@niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; HIV-Associated 

Nephropathy Program Project. 

Date: March 30, 2015. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Michele L. Barnard, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 753, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, (301) 594–8898, 

barnardm@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK R24 Review. 

Date: March 30, 2015. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Robert Wellner, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 706, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–4721, 

rw175w@nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Building a Kidney: 

Cells to Organ. 

Date: April 7, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Marriott at Metro 

Center, 775 12th St. NW., Washington, DC 

20005. 

Contact Person: Paul A. Rushing, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 747, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8895, 

rushingp@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK R24 Grant 

Review. 

Date: April 8, 2015. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Robert Wellner, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 706, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–4721 

rw175w@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05306 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0165] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs 

in Food-Producing Animals: Validation 

of Analytical Methods Used in Residue 

Depletion Studies; Revised 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 revised guidance for 

industry (GFI #208) entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of 

Analytical Methods Used in Residue 

Depletion Studies’’ (VICH GL49(R)). 

This revised guidance, which provides 

minor updates to a final guidance on the 

same topic for which a notice of 

availability was published in the 

Federal Register of September 15, 2011, 

has been developed for veterinary use 

by the International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This revised VICH guidance document 

is intended to provide a general 

description of the criteria that have been 

found by the European Union, Japan, 

United States, Australia, New Zealand, 

and Canada to be suitable for the 

validation of analytical methods used in 

veterinary drug residue depletion 

studies. 

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 

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 guidance 

document. 

Submit electronic comments on the 

revised guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Julia 

Oriani, Center for Veterinary Medicine 

(HFV–151), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0788, 

julia.oriani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 Registration 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12491 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, 

European Medicines Evaluation Agency, 

European Federation of Animal Health, 

Committee on Veterinary Medicinal 

Products, FDA, U.S. Department of 

Agriculture, the Animal Health 

Institute, Japanese Veterinary 

Pharmaceutical Association, Japanese 

Association of Veterinary Biologics, and 

Japanese Ministry of Agriculture, 

Forestry, and Fisheries. 

Six 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, one representative from the 

industry of Canada, one representative 

from the government of South Africa, 

and one representative from the 

industry of South Africa. 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. Revised Guidance on Studies To 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of 

Analytical Methods Used in Residue 

Depletion Studies 

In June 2014, the VICH Steering 

Committee agreed that a revised 

guidance document entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Validation of 

Analytical Methods Used in Residue 

Depletion Studies’’ (VICH GL49(R)) 

should be made available to the public. 

This revised guidance is a revision of a 

final guidance on the same topic for 

which a notice of availability was 

published in the Federal Register of 

September 15, 2011 (76 FR 57056). The 

revised guidance makes minor changes 

such as correcting a typographical error 

in table 2 (Annex 3). Also, the 

explanatory text for table 2 (Annex 3) 

was revised to correct a description of 

the statistical model and to provide an 

explanation of the procedure used to 

generate the data in the table. This 

revised guidance is a product of the 

Metabolism and Residue Kinetics Expert 

Working Group of the VICH. 

During the veterinary drug 

development process, residue depletion 

studies are conducted to determine the 

concentration of the residue or residues 

present in the edible products (tissues, 

milk, eggs, or honey) of animals treated 

with veterinary drugs. This information 

is used in regulatory submissions 

around the world. Submission of 

regulatory methods (i.e., postapproval 

control methods) and the validation 

requirements of the regulatory methods 

are usually well defined by various 

regulatory agencies worldwide and 

might even be defined by national or 

regional law. However, the residue 

depletion studies are generally 

conducted before the regulatory 

methods have been completed. 

Oftentimes the in-house validated 

residue methods provide the framework 

for the methods submitted for regulatory 

monitoring. Harmonization of the 

validation requirements for 

methodology used during residue 

depletion studies and submitted to the 

regulatory agencies in support of the 

maximum residue limits and 

withdrawal periods should be 

achievable. It is the intent of this 

document to describe a validation 

procedure that is acceptable to the 

regulatory bodies of the VICH regions 

for use in the residue depletion studies. 

This validated method could continue 

on to become the ‘‘regulatory method’’ 

but that phase of the process will not be 

addressed in any detail in this guidance. 

For purposes of this guidance, the term 

‘‘acceptable’’ refers to the scientific 

evaluation of the analytical method in 

terms of the described validation 

criteria, not to acceptance of the 

analytical method as satisfying the 

applicable national/regional laws and 

regulations of any of the relevant 

regulatory bodies. 

III. Significance of Guidance 

As a result of Level 2 revisions, this 

VICH revised guidance is being issued 

in final, consistent with FDA’s good 

guidance practice (GGP) regulations at 

21 CFR 10.115(g)(4). This guidance, 

developed under the VICH process, has 

been revised to conform to FDA’s GGP 

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. 

This VICH guidance represents 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 revised 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 have 

been approved under OMB control 

number 0910–0032. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to 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. 

VI. 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: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05346 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1152] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Petition To 

Request an Exemption From 100 

Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

mstockstill on DSK4VPTVN1PROD with NOTICES