Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Notices 38695 

the terms as outlined in the FY 2017 

Notice of Award for each program. 

DATES: Funds will be realloted after 

September 1, 2017 and before 

September 30, 2017. 

ADDRESSES: The reallotment amounts to 

SCDDs and P&As can be found at 

https://www.acl.gov/node/110. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Morris, Office of Policy and 

Development, Center on Policy & 

Evaluation, Administration for 

Community Living, 330 C St. SW., 

Washington, DC 20201. Telephone (202) 

795–7408. Email andrew.morris@

acl.hhs.gov. Please note the telephone 

number is not toll free. This document 

will be made available in alternative 

formats upon request. Written 

correspondence can be sent to 

Administration for Community Living, 

U.S. Department of Health and Human 

Services, 330 C St. SW., Washington, DC 

20201. 

Dated: August 4, 2017. 

Melissa Ortiz, 

Commissioner, Administration on 

Disabilities. 

[FR Doc. 2017–17195 Filed 8–14–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–1197] 

The Food and Drug Administration’s 

Proposed Method for Adjusting Data 

on Antimicrobials Sold or Distributed 

for Use in Food-Producing Animals 

Using a Biomass Denominator; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability for public 

comment of a proposed method for 

applying a food animal biomass 

denominator to annual data on 

antimicrobials sold and distributed for 

use in food animals in the United States. 

This method will allow us to obtain a 

corrected estimate of antimicrobial drug 

sales relative to the animal population 

potentially being treated with those 

drugs, thereby lending further context to 

the antimicrobial sales data we are 

collecting and analyzing. 

DATES: Submit either electronic or 

written comments on the proposed 

method by November 13, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2017–N–1197 for ‘‘FDA’s Proposed 

Method for Adjusting Data on 

Antimicrobials Sold or Distributed for 

Use in Food-Producing Animals Using a 

Biomass Denominator.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 proposed method to the 

Policy and Regulations Staff (HFV–6), 

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 requests. 

Persons with access to the Internet may 

obtain the proposed method at either 

https://www.fda.gov/ForIndustry/User

Fees/AnimalDrugUserFeeAct 

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38696 Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Notices 

ADUFA/ucm042896.htm or in this 

docket at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Sujaya Dessai, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5671, 

sujaya.dessai@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Animal 

drug sponsors are required to report 

annually to FDA the amount of 

antimicrobials sold or distributed for 

use in food-producing animals and 

provide species-specific estimates of the 

percentage of their drug product sales 

for use in any of the four major foodproducing species (cattle, swine, 

chickens, and turkeys) identified on the 

approved product label (21 CFR 

514.87(c)). FDA is announcing the 

availability of a proposed method for 

using a biomass denominator to adjust 

these sales data. The proposed method 

will provide estimates of annual 

antimicrobial drug sales adjusted for the 

size of the animal population (the 

animal biomass of each such species) 

potentially being treated with those 

drugs. The adjusted estimates will 

provide insight into broad shifts in the 

amount of antimicrobials sold for use in 

food-producing animals and give the 

Agency a more nuanced view of why 

sales increase or decrease over time in 

a manner that is specific to U.S. animal 

production. Such analysis will also 

support our ongoing efforts to encourage 

the judicious use of antimicrobials in 

food-producing animals to help ensure 

the continued availability of safe and 

effective antimicrobials for animals and 

humans. 

Application of a biomass denominator 

to normalize antimicrobial sales data 

has been used internationally. In 

developing this proposal for applying a 

biomass denominator to antimicrobial 

sales data in the United States, FDA has 

considered methods being utilized and 

discussed in other countries. FDA’s 

intent in publishing the proposed 

method is to initiate discussion with 

stakeholders on the biomass correction 

method FDA is considering, and to seek 

comment on the methodology and the 

utility of this type of data analysis. 

Dated: August 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17206 Filed 8–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Special Emphasis Panel; Alzheimer’s 

Disease Drug Development. 

Date: September 15, 2017. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway, Suite 2W200, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Alexander Parsadanian, 

Ph.D., Scientific Review Officer, National 

Institute on Aging, Gateway Building 2C/212, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, 301–496–9666, parsadaniana@

nia.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; AD 

Sequencing Project Data Analysis. 

Date: September 20, 2017. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway, Suite 2W200, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Alexander Parsadanian, 

Ph.D., Scientific Review Officer, National 

Institute on Aging, Gateway Building 2C/212, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, 301–496–9666, parsadaniana@

nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 8, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–17155 Filed 8–14–17; 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 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: Environmental Health 

Sciences Review Committee. 

Date: August 29–30, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Imperial Hotel and 

Convention Center, 4700 Emperor Boulevard, 

Durham, NC 27703. 

Contact Person: Linda K. Bass, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat’l Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30, 

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

1307. 

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: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; 1 P30 Core Center Conflict 

Review. 

Date: August 30, 2017. 

Time: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Imperial Hotel and 

Convention Center, 4700 Emperor Boulevard, 

Durham, NC 27703. 

Contact Person: Leroy Worth, Ph.D., 

Scientific Review Officer Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat. Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30/ 

Room 3171, Research Triangle Park, NC 

27709, 919/541–0670, worth@niehs.nih.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. 

(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 

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