Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12501 

shall provide such person a written 

statement of the classification (if any) of 

such device and the requirements of the 

FD&C Act applicable to the device. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; FDA and 

Industry Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act’’ 

establishes procedures for submitting, 

reviewing, and responding to requests 

for information respecting the class in 

which a device has been classified or 

the requirements applicable to a device 

under the FD&C Act that are submitted 

in accordance with section 513(g) of the 

FD&C Act. FDA does not review data 

related to substantial equivalence or 

safety and effectiveness in a 513(g) 

request for information. FDA’s 

responses to 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. Additionally, the FD&C 

Act, as amended by the FDA 

Amendments Act of 2007 (Public Law 

110–85), requires FDA to collect user 

fees for 513(g) requests for information. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; User Fees for 

513(g) Requests for Information’’ assists 

FDA staff and regulated industry by 

describing the user fees associated with 

513(g) requests. The Medical Device 

User Fee Cover Sheet (Form FDA 3601), 

which accompanies the supplemental 

material described in this information 

collection, is approved under OMB 

control number 0910–0511 and expires 

April 30, 2016. 

In the Federal Register of July 22, 

2014 (79 FR 42517), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Devices and Radiological Health 513(g) requests ............. 114 1 114 12 1,368 

Center for Biologics Evaluation and Research 513(g) requests ......... 4 1 4 12 48 

Total .............................................................................................. .................... ........................ .................... .................... 1,416 

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

Respondents to this collection of 

information are mostly device 

manufacturers; however, anyone may 

submit a 513(g) request for information. 

The total number of annual responses is 

based on the average number of 513(g) 

requests received each year by the 

Agency. 

Dated: March 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05358 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–2010–D–0166] 

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: Marker 

Residue Depletion Studies To 

Establish Product Withdrawal Periods; 

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 #207) entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue 

Depletion Studies to Establish Product 

Withdrawal Periods’’ (VICH GL48(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 

(2011 guidance), 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 is 

intended to provide study design 

recommendations that will facilitate the 

universal acceptance of the generated 

residue depletion data to fulfill the 

national/regional requirements. 

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 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: 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

12502 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

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 

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: Marker Residue 

Depletion Studies To Establish Product 

Withdrawal Periods 

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: Marker Residue 

Depletion Studies to Establish Product 

Withdrawal Periods’’ (VICH GL48(R)) 

should be made available to the public. 

The 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 includes minor 

changes that clarify recommendations 

for conducting a single timepoint study 

for products proposed for a 0-day 

withdrawal period or a 0-day milk 

discard time. In addition, the design for 

a 0-day milk discard timestudy was 

described, and a definition for 

preruminant was added. This revised 

guidance is a product of the Metabolism 

and Residue Kinetics Expert Working 

Group of the VICH. 

As part of the approval process for 

veterinary medicinal products in foodproducing animals, national/regional 

regulatory authorities require data from 

marker residue depletion studies in 

order to establish appropriate 

withdrawal periods in edible tissues, 

including meat, milk, and eggs. The 

objective of this guidance is to provide 

study design recommendations that will 

facilitate the universal acceptance of the 

generated residue depletion data to 

fulfill the national/regional 

requirements. 

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. 2015–05345 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–2007–D–0369] 

Product-Specific Bioequivalence 

Recommendations; Draft and Revised 

Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific bioequivalence (BE) 

recommendations. The 

recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site. The BE 

recommendations identified in this 

notice were developed using the process 

described in that guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

mstockstill on DSK4VPTVN1PROD with NOTICES