40010 Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–1804] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

General Approach To Establish an 

Acute Reference Dose; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry (GFI) #232 

entitled ‘‘Studies to Evaluate the Safety 

of Residues of Veterinary Drugs in 

Human Food: General Approach to 

Establish an Acute Reference Dose’’ 

(VICH GL54). This guidance has been 

developed for veterinary use by the 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This VICH guidance document is 

intended to address the nature and 

types of data that can be useful in 

determining a toxicological acute 

reference dose (ARfD) for residues of 

veterinary drugs, the studies that may 

generate such data, and how the ARfD 

may be calculated based on these data. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–D–1804 for ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: General 

Approach to Establish an Acute 

Reference Dose.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

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, 7500 Standish Pl., 

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

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tong Zhou, Center for Veterinary 

Medicine (HFV–153), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0826, 

Tong.Zhou@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

GFI #232 entitled ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: General 

Approach to Establish an Acute 

Reference Dose’’ (VICH GL54). 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 is 

committed to seeking scientifically 

based harmonized technical procedures 

for pharmaceutical development. 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 Council for Harmonisation 

of Technical Requirements for 

Pharmaceuticals for Human Use for 

several years to develop, with input 

from both regulatory and industry 

representatives, harmonized technical 

requirements for the registration or 

approval of pharmaceutical products for 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40011 

human use 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 and 

European Medicines Agency; 

International Federation for Animal 

Health—Europe; FDA; the U.S. 

Department of Agriculture; the U.S. 

Animal Health Institute; the Japanese 

Ministry of Agriculture, Forestry, and 

Fisheries; and the Japanese Veterinary 

Products Association. 

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 in Canada, one representative 

from the government of South Africa, 

and one representative from the 

industry in South Africa. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by HealthforAnimals. 

II. Guidance for Industry on Studies To 

Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

General Approach To Establish an 

Acute Reference Dose 

In the Federal Register of June 1, 2015 

(80 FR 31041), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Studies to Evaluate the Safety 

of Residues of Veterinary Drugs in 

Human Food: General Approach to 

Establish an Acute Reference Dose’’ 

(VICH GL54) giving interested persons 

until July 31, 2015, to comment on the 

draft guidance. FDA received two 

comments on the draft guidance, and 

those comments, as well as those 

received by other VICH member 

regulatory agencies, were considered as 

the guidance was finalized. The 

guidance announced in this notice 

finalizes the draft guidance dated June 

1, 2015. The final guidance is a product 

of the Safety Expert Working Group of 

the VICH. 

This VICH guidance document is 

intended to address the nature and 

types of data that can be useful in 

determining a toxicological ARfD for 

residues of veterinary drugs, the studies 

that may generate such data, and how 

the ARfD may be calculated based on 

these data. 

III. Significance of Guidance 

This guidance, developed under the 

VICH process, is being issued consistent 

with 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 guidance represents the current 

thinking of FDA on ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: General 

Approach to Establish an Acute 

Reference Dose.’’ 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. This is not a 

significant regulatory action subject to 

Executive Order 12866. 

IV. 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 Action 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. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: August 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17872 Filed 8–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1956] 

Identifying Trading Partners Under the 

Drug Supply Chain Security Act; Draft 

Guidance for Industry; Availability 

Correction 

Notice document 2017–17569, 

appearing on pages 39589 through 

39590, in the issue of Monday, August 

21, 2017, was published in error. It 

should be removed. 

[FR Doc. C1–2017–17569 Filed 8–22–17; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development Meetings; Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 

Child Health and Human Development Initial 

Review Group Health, Behavior, and Context 

Subcommittee. 

Date: October 16–26, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Kimberly L. Houston, MD, 

Scientific Review Officer, Eunice Kennedy 

Shriver National Institute of Children Health 

and Human Development, 6701B Rockledge 

Drive, Room 2127B, Bethesda, MD 20892, 

301–827–4902, kimberly.houston@nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; NICHD International 

and Domestic Pediatric and Maternal HIV 

and Other High Priority Infectious Diseases 

Data Coordinating Center. 

Date: October 18, 2017. 


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