27334 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

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 the Federal Register of July 21, 

2016 (81 FR 47397), FDA published the 

notice of availability for a draft revised 

GFI #3 entitled ‘‘General Principles for 

Evaluating the Human Food Safety of 

New Animal Drugs Used in FoodProducing Animals’’ giving interested 

persons until September 19, 2016, to 

comment on the draft revised GFI. FDA 

received several comments on the draft 

revised GFI, and those comments were 

considered as the guidance was 

finalized. Revisions to the document 

were made for accuracy and 

clarification based on comments 

received from the public, including 

reinsertion of information specific to 

endogenous sex steroids, and minor 

editorial edits. The guidance announced 

in this notice finalizes the draft revised 

GFI dated July 2016. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘General Principles 

for Evaluating the Human Food Safety 

of New Animal Drugs Used in FoodProducing Animals.’’ 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 

guidance is not subject to Executive 

Order 12866. 

III. 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 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. 

IV. 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: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12607 Filed 6–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine: Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, Lister Hill National Center 

for Biomedical Communications. 

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 as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for review, discussion, and evaluation of 

individual intramural programs and 

projects conducted by the National 

Library of Medicine, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, Lister Hill National Center for 

Biomedical Communications. 

Date: September 6–7, 2018. 

Open: September 6, 2018, 9:00 a.m. to 

12:00 p.m. 

Agenda: Review of research and 

development programs and preparation of 

reports of the Lister Hill National Center for 

Biomedical Communications. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Closed: September 6, 2018, 12:00 p.m. to 

4:30 p.m. 

Agenda: To review and evaluate personal 

qualifications, performance, and competence 

of individual investigators. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Closed: September 7, 2018, 9:00 a.m. to 

10:00 a.m. 

Agenda: To review and evaluate personal 

qualifications, performance, and competence 

of individual investigators. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 27335 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Contact Person: Karen Steely, Program 

Assistant, Lister Hill National Center for 

Biomedical Communications, National 

Library of Medicine, Building 38A, Room 

7S707, Bethesda, MD 20892, 301–827–4385, 

ksteely@mail.nih.gov. 

Open: September 7, 2018, 10:00 a.m. to 

11:30 a.m. 

Agenda: Review of research and 

development programs and preparation of 

reports of the Lister Hill National Center for 

Biomedical Communications. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Contact Person: Karen Steely, Program 

Assistant, Lister Hill National Center for 

Biomedical Communications, National 

Library of Medicine, Building 38A, Room 

7S707, Bethesda, MD 20892, 301–827–4385, 

ksteely@mail.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. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS) 

Dated: June 6, 2018. 

Michelle D. Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12534 Filed 6–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

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 materials, 

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: Biomedical 

Informatics, Library and Data Sciences 

Review Committee. 

Date: November 15–16, 2018. 

Time: November 15, 2018, 8:00 a.m. to 5:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Hyatt, 1 Bethesda Metro 

Center, Bethesda, MD 20814. 

Time: November 16, 2018, 8:00 a.m. to 5:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Contact Person: Zoe E. Huang, MD, Acting 

Chief Scientific Review Officer, Scientific 

Review Office, Extramural Programs, 

National Library of Medicine, NIH, 6705 

Rockledge Drive, Suite 301, Bethesda, MD 

20892–7968, 301–594–4937, huangz@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS) 

Dated: June 6, 2018. 

Michelle D. Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12536 Filed 6–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Planning for 

Non-Communicable Diseases and Disorders 

Research Training Programs in Low and 

Middle Income Countries (D71). 

Date: June 21, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Fungai Chanetsa, MPH, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3135, 

MSC 7770, Bethesda, MD 20892, 301–408– 

9436, fungai.chanetsa@nih.hhs.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: Center for Scientific 

Review Special Emphasis Panel; Research on 

Current Topics in Alzheimer’s Disease and 

Its Related Dementias. 

Date: July 2–3, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Michael Selmanoff, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5164, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, selmanom@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Computational Structural Biology. 

Date: July 9, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Sergei Ruvinov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4158, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1180, ruvinser@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Cell Biology, Developmental 

Biology, and Bioengineering. 

Date: July 10–11, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda 

(Formerly Holiday Inn Select), 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Alexander Gubin, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4196, 

MSC 7812, Bethesda, MD 20892, 301–435– 

2902, gubina@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group, AIDSassociated Opportunistic Infections and 

Cancer Study Section. 

Date: July 10, 2018. 

Time: 8:00 a.m. to 6:00 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: Eduardo A. Montalvo, 

Ph.D., Scientific Review Officer, Center for 


sradovich on DSK3GMQ082PROD with NOTICES