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 

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12492 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice invites comments on 

the information collection provisions of 

our existing regulations governing 

petitions to request an exemption from 

100 percent identity testing of dietary 

ingredients. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 8, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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—21 CFR 111.75(a)(1)(ii) 

(OMB Control Number 0910–0608)— 

(Extension) 

The Dietary Supplement Health and 

Education Act (DSHEA) (Pub. L. 103– 

417) added section 402(g) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 342(g)), which provides, 

in part, that the Secretary of Health and 

Human Services (the Secretary) may, by 

regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g)(1) of the 

FD&C Act states that a dietary 

supplement is adulterated if ‘‘it has 

been prepared, packed, or held under 

conditions that do not meet current 

good manufacturing practice 

regulations.’’ Section 701(a) of the FD&C 

Act (21 U.S.C. 371(a)) gives us the 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

Part 111 (21 CFR part 111) establishes 

the minimum Current Good 

Manufacturing Practice (CGMP) 

necessary for activities related to 

manufacturing, packaging, labeling, or 

holding dietary supplements to ensure 

the quality of the dietary supplement. 

Section 111.75(a)(1) of our regulations 

(21 CFR 111.75(a)(1)) establishes a 

procedure for a petition to request an 

exemption from 100 percent identity 

testing of dietary ingredients. Under 

§ 111.75(a)(1)(ii), manufacturers may 

request an exemption from the 

requirements set forth in 

§ 111.75(a)(1)(i) when the dietary 

ingredient is obtained from one or more 

suppliers identified in the petition. The 

regulation clarifies that we are willing to 

consider, on a case-by-case basis, a 

manufacturer’s conclusion, supported 

by appropriate data and information in 

the petition submission, that it has 

developed a system that it would 

implement as a sound, consistent means 

of establishing, with no material 

diminution of assurance compared to 

the assurance provided by 100 percent 

identity testing, the identity of the 

dietary ingredient before use. 

Section 111.75(a)(1) reflects our 

determination that manufacturers that 

test or examine 100 percent of the 

incoming dietary ingredients for 

identity can be assured of the identity 

of the ingredient. However, we 

recognize that it may be possible for a 

manufacturer to demonstrate, through 

various methods and processes in use 

over time for its particular operation, 

that a system of less than 100 percent 

identity testing would result in no 

material diminution of assurance of the 

identity of the dietary ingredient as 

compared to the assurance provided by 

100 percent identity testing. To provide 

an opportunity for a manufacturer to 

make such a showing and reduce the 

frequency of identity testing of 

components that are dietary ingredients 

from 100 percent to some lower 

frequency, we added to § 111.75(a)(1), 

an exemption from the requirement of 

100 percent identity testing when a 

manufacturer petitions the Agency for 

such an exemption to 100 percent 

identity testing under § 10.30 (21 CFR 

10.30) and the Agency grants such 

exemption. Such a procedure would be 

consistent with our stated goal, as 

described in the CGMP final rule, of 

providing flexibility in the CGMP 

requirements. Section 111.75(a)(1)(ii) 

sets forth the information a 

manufacturer is required to submit in 

such a petition. The regulation also 

contains a requirement to ensure that 

the manufacturer keeps our response to 

a petition submitted under 

§ 111.75(a)(1)(ii) as a record under 

§ 111.95 (21 CFR 111.95). The collection 

of information in § 111.95 has been 

approved under OMB control number 

0910–0606. 

Description of Respondents: The 

respondents to this collection of 

information are firms in the dietary 

supplement industry, including dietary 

supplement manufacturers, packagers 

and re-packagers, holders, labelers and 

re-labelers, distributors, warehouses, 

exporters, importers, large businesses, 

and small businesses. 

We estimate the burden of this 

collection of information as follows: 

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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12493 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; CGMP requirements for dietary supplements Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

111.75(a)(1)(ii) ..................................................................................... 1 1 1 8 8 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In the last 3 years, we have not 

received any new petitions to request an 

exemption from 100 percent identity 

testing of dietary ingredients; therefore, 

the Agency estimates that one or fewer 

petitions will be submitted annually. 

Based on our experience with petition 

processes, we estimate it will take a 

requestor about 8 hours to prepare the 

factual and legal information necessary 

to support a petition for exemption and 

to prepare the petition. Although we 

have not received any new petitions to 

request an exemption from 100 percent 

identity testing of dietary ingredients in 

the last 3 years, we believe that OMB 

approval of these information collection 

provisions should be extended to 

provide for the potential future need of 

a firm in the dietary supplement 

industry to petition for an exemption 

from 100 percent identity testing of 

dietary ingredients. 

Dated: March 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05357 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting of the National Advisory 

Council for Healthcare Research and 

Quality 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: In accordance with section 

10(a) of the Federal Advisory Committee 

Act, 5 U.S.C. App. 2, this notice 

announces a meeting of the National 

Advisory Council for Healthcare 

Research and Quality. 

DATES: The meeting will be held on 

Friday, March 27, 2015, from 8:30 a.m. 

to 3:00 p.m. 

ADDRESSES: The meeting will be held at 

the Eisenberg Conference Center, 

Agency for Healthcare Research and 

Quality, 540 Gaither Road, Rockville, 

Maryland 20850. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Zimmerman, Designated 

Management Official, at the Agency for 

Healthcare Research and Quality, 540 

Gaither Road, Rockville, Maryland 

20850, (301) 427–1456. For press-related 

information, please contact Alison Hunt 

at (301) 427–1244. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Diversity Management 

on (301) 827–4840, no later than Friday, 

March 13, 2015. The agenda, roster, and 

minutes are available from Ms. Bonnie 

Campbell, Committee Management 

Officer, Agency for Healthcare Research 

and Quality, 540 Gaither Road, 

Rockville, Maryland 20850. Ms. 

Campbell’s phone number is (301) 427– 

1554. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

The National Advisory Council for 

Healthcare Research and Quality is 

authorized by Section 941 of the Public 

Health Service Act, 42 U.S.C. 299c. In 

accordance with its statutory mandate, 

the Council is to advise the Secretary of 

the Department of Health and Human 

Services and the Director, Agency for 

Healthcare Research and Quality 

(AHRQ), on matters related to AHRQ’s 

conduct of its mission including 

providing guidance on (A) priorities for 

health care research, (B) the field of 

health care research including training 

needs and information dissemination on 

health care quality and (C) the role of 

the Agency in light of private sector 

activity and opportunities for public 

private partnerships. 

The Council is composed of members 

of the public, appointed by the 

Secretary, and Federal ex-officio 

members specified in the authorizing 

legislation. 

II. Agenda 

On Friday, March 27, 2015, there will 

be a subcommittee meeting for the 

National Healthcare Quality and 

Disparities Report scheduled to begin at 

7:30 a.m. The subcommittee meeting is 

open the public. The Council meeting 

will convene at 8:30 a.m., with the call 

to order by the Council Chair and 

approval of previous Council summary 

notes. The meeting is open to the public 

and will be available via webcast at 

www.webconferences.com/ahrq . The 

meeting will begin with the AHRQ 

Director presenting an update on 

current research, programs, and 

initiatives. Following the Director’s 

Update, the agenda will include an 

update on AHRQ insurance-related 

research and a discussion of Patient 

Centered Outcomes Research (PCOR) 

Dissemination and Implementation. The 

final agenda will be available on the 

AHRQ Web site at www.AHRQ.gov no 

later than Friday, March 20, 2015. 

Dated: March 4, 2015. 

Carla Ladner, 

Correspondence Analyst. 

[FR Doc. 2015–05399 Filed 3–6–15; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Hepatitis B Research 

Network. 

Date: March 25, 2015. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSK4VPTVN1PROD with NOTICES