48822 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 

collection under 45 CFR 1355.41–.47 to 

be implemented October 1, 2019. 

Commenters addressed support for the 

collection of information under the 

Indian Child Welfare Act and other 

areas covered by the new requirements. 

ACF received no comment on the 

specific burden hours for the existing 

AFCARS requirements undergoing 

renewal. 

AFCARS is mandated by 42 U.S.C. 

679. The regulation at 45 CFR 1355.40 

and the appendices to 45 CFR 1355 set 

forth the requirements of section 479 of 

the Social Security Act for the collection 

of uniform, reliable information on 

children who are under the 

responsibility of the State or Tribal title 

IV–B/IV–E agency for placement, care, 

and adoption. The AFCARS 

requirements under 45 CFR 1355.40 

have been in effect since October 1, 

1993 for States. In 2009, section 479B(b) 

of the Act was enacted authorizing 

direct Federal funding of Indian Tribes, 

Tribal organizations, and Tribal 

consortia that choose to operate a foster 

care, adoption assistance and, at Tribal 

option, a kinship guardianship 

assistance program under title IV–E of 

the Act. The data collected informs 

State/Tribal/Federal policy decisions, 

program management, and responses to 

Congressional and Departmental 

inquiries. 

Respondents: Title IV–E State and 

Tribal Child Welfare Agencies. 

ESTIMATED TOTAL ANNUAL BURDEN HOURS

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

AFCARS .......................................................................................................... 59 2 2,188 258,215 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 258,215 

Additional Information: Copies of the 

regulation containing the data elements 

may be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW., 

Washington, DC 20201. Attention 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Mary Jones, 

ACF/OPRE Reports Clearance Officer. 

[FR Doc. 2017–22720 Filed 10–19–17; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1229] 

Current Good Manufacturing Practice 

Requirements for Food for Animals; 

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 #235 entitled 

‘‘Current Good Manufacturing Practice 

Requirements for Food for Animals.’’ 

This guidance helps domestic and 

foreign facilities that are required to 

register as food facilities under the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) determine whether and 

how they need to comply with the 

current good manufacturing practice 

requirements of the Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals final rule. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 20, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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– 

2016–D–1229 for ‘‘Current Good 

Manufacturing Practice Requirements 


srobinson on DSKBC5CHB2PROD with NOTICES
Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48823 

for Food for Animals.’’ 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 

office 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 requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jeanette Murphy, Center for Veterinary 

Medicine (HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6246, 

Jenny.Murphy@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 25, 

2016 (81 FR 58519), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Current Good Manufacturing 

Practice Requirements for Food for 

Animals,’’ giving interested persons 

until November 23, 2016, to comment 

on the draft guidance. FDA received 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. Changes made 

include additional explanation and 

examples and the inclusion of a part 507 

(21 CFR part 507) Current Good 

Manufacturing Practice (CGMP) SelfAssessment Tool in Appendix B to 

assist facilities in reviewing the 

implementation of CGMP requirements 

at their facility. Information regarding 

human food by-products for use as food 

for animals was removed; this 

information is contained in draft GFI 

#239, entitled ‘‘Human Food ByProducts for Use as Animal Food’’ (81 

FR 58521, August 25, 2016). In addition, 

editorial changes were made to improve 

clarity. The guidance announced in this 

notice finalizes the draft guidance dated 

August 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 current good 

manufacturing practice requirements for 

food for 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 

part 507 have been approved under 

OMB control number 0910–0789. 

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: October 16, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22730 Filed 10–19–17; 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 Guidances for 

Salmeterol Xinafoate and Fluticasone 

Propionate; Draft Guidances 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 three 

draft guidances for industry on generic 

salmeterol xinafoate inhalation powder, 

fluticasone propionate inhalation 

aerosol, and fluticasone propionate 

inhalation powder, entitled ‘‘Draft 

Guidance on Salmeteral Xinafoate’’ and 

‘‘Draft Guidance on Fluticasone 

Propionate.’’ The guidances, when 

finalized, will provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs) for 

salmeterol xinafoate inhalation powder, 

fluticasone propionate inhalation 

aerosol, and fluticasone propionate 

inhalation powder. 

DATES: Submit either electronic or 

written comments on the draft 

guidances by December 19, 2017 to 

ensure that the Agency considers your 

comment on this draft guidance before 

it begins work on the final version of the 

guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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 


srobinson on DSKBC5CHB2PROD with NOTICES