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notice of availability for a draft guidance 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draft guidance.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comments on the draft guidance, and 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finalizes the draft guidance dated June 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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
40012 Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6710 B 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

Ph.D., Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6701B Rockledge Drive, Room, 

Bethesda, MD 20892, (301) 435–6680, 

skandasa@mail.nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel. 

Date: November 06, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Kimberly Lynette 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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209 Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: August 17, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–17791 Filed 8–22–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Environmental Health Sciences Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting 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 Advisory 

Environmental Health Sciences Council. 

Date: September 12–13, 2017. 

Closed: September 12, 2017, 8:30 a.m. to 

9:15 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Open: September 12, 2017, 9:30 a.m. to 

4:30 p.m. 

Agenda: Discussion of Program and Issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Open: September 13, 2017, 8:30 a.m. to 

11:00 a.m. 

Agenda: Discussion of Program and Issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Contact Person: Gwen W. Collman, Ph.D., 

Interim Director, Division of Extramural 

Research & Training, National Institutes of 

Health, Nat. Inst. of Environmental Health 

Sciences, 615 Davis Dr., KEY615/3112, 

Research Triangle Park, NC 27709, (919) 541– 

4980, collman@niehs.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.niehs.nih.gov/dert/c-agenda.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: August 17, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–17796 Filed 8–22–17; 8:45 am] 

BILLING CODE 4140–01–P 

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; Function, Integration, and 

Rehabilitation Sciences Subcommittee. 

Date: October 6, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW., 

Washington, DC 20015. 

Contact Person: Joanna Kubler-Kielb, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, 6710B Rockledge 

Drive, Rm., Bethesda, MD 20892–7501, 301– 

435–6916, kielbj@mail.nih.gov. 

Population Sciences Subcommittee, 

Population Sciences Committee. 

Date: October 17, 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: Minki Chatterji, Scientific 

Review Officer, Scientific Review Branch, 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development, NIH, 

DHHS, 6710B Rockledge Drive, Rm. 2121D, 

Bethesda, MD 20892–7501, 301–827–5435, 

minki.chatterji@nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Archiving and 

Documenting Child Health and Human 

Development Data Sets. 

Date: October 17, 2017. 

Time: 5:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Minki Chatterji, Scientific 

Review Officer, Scientific Review Branch, 


asabaliauskas on DSKBBXCHB2PROD with NOTICES