Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43381 

(Rehabilitation Act), as amended by the 

Workforce Innovation and Opportunity 

Act (WIOA, Pub. L. 113–128), and the 

corresponding regulations at 45 CFR 

part 1329, require centers for 

independent living (CILs) to submit 

annual performance reports to the 

Administrator of the Administration for 

Community Living (ACL) in order to 

receive continuation funding under the 

IL Parts B and C programs. 

The 704 reports are submitted 

annually by all Centers for Independent 

Living, designated State entities and 

Statewide Independent Living Councils 

receiving IL Parts B and C funds. The 

704 Parts I and II reports are used by 

ACL to assess grantees’ compliance with 

title VII of the Act, with section 1329 of 

the Code of Federal Regulations, and 

with applicable provisions of the HHS 

regulations at 45 CFR part 75. The 704 

Parts I and II reports serve as the 

primary basis for ACL’s monitoring 

activities in fulfillment of its 

responsibilities under sections 706 and 

722 of the Act. The 704 Parts I and II 

reports also enable ACL to collect 

qualitative and quantitative data to track 

performance outcomes and efficiency 

measures of the IL programs with 

respect to the annual and long-term 

performance targets established in 

compliance with the GPRA 

Modernization Act of 2010 (GPRAMA) 

reporting requirements. The 704 Parts I 

and II reports are also used by ACL to 

design CIL and SILC training and 

technical assistance programs 

authorized by section 721 of the Act. 

Comments in Response to the 60-Day 

Federal Register Notice 

A 60-day notice was published in the 

Federal Register in Vol. 82, No. 35, pg. 

11471 on February 23rd, 2017. A Notice 

of Correction was published in the 

Federal Register in Vol. 82, No. 42 pg. 

12610 on March 6th, 2017, announcing 

that ACL had made changes to the 

submission instructions, the public 

comments closing date was incorrect, 

the public comments email box was 

incorrect, and the core services were 

misstated in the original Federal 

Register posting ACL received 

comments from 50 (Fifty) organizations 

that provided 221 (Two Hundred and 

Twenty-One) individual comments 

about the proposed information 

collection. ACL reviewed all of the 

comments. The majority of the 

comments that ACL received expressed 

concerns over inclusion of sexual 

orientation and gender identity 

questions in the reporting instrument 

and asked that those questions be 

removed; the separate demographics 

and services provided to individuals 

with significant disabilities, and the 

need for clarification on the definitions 

and instructions as well as revisions to 

the IL core services and additional 

services sections of the updated 

reporting instrument. Further 

deliberation is needed to ensure that we 

appropriately address all of the 

concerns. This work will inform a 

redesign of the proposed information 

collection forms prior to the expiration 

of the extension. 

Annual Burden Estimates 

A copy of the existing Centers for 

Independent Living (CILs), designated 

State entities (DSEs) and Statewide 

Independent Living Councils (SILCs) 

Annual Performance Reports (704 Parts 

I and II reports can be found on ACL’s 

Web site at: https://www.acl.gov/aboutacl/public-input. The 704 Report’s 

estimated hour burden per respondent 

each for the Part I (IL Part B) and Part 

II (IL Part C) in 2017 remains unchanged 

at 35 hours from 2014 because the 

current data collection instrument is the 

same as the one approved in 2014. 

The total estimated hour burden also 

remains the same because the number of 

respondents, 412, has not changed since 

the 2014 approval. 

The aggregate total hour burden for 

412 Parts I and II 704 Report is 

estimated at 14,385, as follows: 

Report 

Number of 

DSEs and 

SILCs 

(Part B) 

Frequency of 

responses 

per year 

Average 

burden hours 

per response 

Total annual 

burden hours 

704 Report, Part I ............................................................................................ 55 1 35 1,925 

Report 

Number of 

IL Centers 

(Part C) 

Frequency of 

responses 

per year 

Average 

burden hours 

per response 

Total annual 

burden hours 

704 Report, Part II ........................................................................................... 356 1 35 12,460 

Estimated Total Annual Burden 

Hours: 14,385. 

Dated: September 11, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–19560 Filed 9–14–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–2462] 

The Index of Legally Marketed 

Unapproved New Animal Drugs for 

Minor Species; Draft 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 draft 

guidance for industry (GIF) #210 

entitled ‘‘The Index of Legally Marketed 

Unapproved New Animal Drugs for 

Minor Species.’’ This draft guidance 

describes the process for adding a new 

animal drug to the Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species (the Index). 

The Index consists of a list of legally 

marketed unapproved new animal drugs 

for minor species that meet the 

requirements of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2017 to ensure that the 

Agency considers your comments 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: 

mstockstill on DSK30JT082PROD with NOTICES

43382 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

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–D–2462 for ‘‘The Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species.’’ 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. 

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, 7519 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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Dorothy Bailey, Center for Veterinary 

Medicine (HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0565, 

dorothy.bailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Minor Use and Minor Species 

Animal Health Act of 2004 (MUMS Act) 

(Pub. L. 108–282) amended the FD&C 

Act to provide animal drug companies 

with incentives to develop new animal 

drugs for minor species and minor uses 

in major species, while still ensuring 

appropriate safeguards for animal and 

human health. 

One of the incentives established by 

the MUMS Act is the Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species, also referred to 

as ‘‘the Index.’’ The Index is available 

for new animal drugs intended for use 

in minor species; the Index is not 

available for drugs intended for minor 

use in major species (horses, cattle, pigs, 

turkeys, chickens, dogs, and cats). 

The Index consists of a list of legally 

marketed unapproved new animal drugs 

for minor species that meet the 

requirements of section 572 of the FD&C 

Act (21 U.S.C. 360ccc–1). We refer to 

the process of adding a new animal drug 

to the Index as ‘‘indexing.’’ Indexing 

represents a pathway for legally 

marketing unapproved new animal 

drugs for minor species. 

In the Federal Register of December 6, 

2007, FDA published final regulations 

establishing administrative procedures 

and criteria for listing a new animal 

drug for use in a minor species in the 

Index (72 FR 69108). These regulations, 

which are codified at 21 CFR part 516, 

subpart C, are administered by the 

Office of Minor Use and Minor Species 

Animal Drug Development (OMUMS) 

within FDA’s Center for Veterinary 

Medicine (CVM). That office also 

maintains the Index, which is available 

to the public through FDA’s Web site at 

http://www.fda.gov/AnimalVeterinary/ 

DevelopmentApprovalProcess/ 

MinorUseMinorSpecies/ 

ucm125452.htm. 

FDA is announcing the availability of 

a draft GIF #210 entitled ‘‘The Index of 

Legally Marketed Unapproved New 

Animal Drugs for Minor Species.’’ This 

draft guidance describes the process for 

adding a new animal drug to the Index. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘The Index of 

Legally Marketed Unapproved New 

Animal Drugs for Minor Species.’’ 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 draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43383 

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 516.119 

through 516.165 have been approved 

under OMB control number 0910–0620. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19609 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–4792] 

Regulatory Considerations for 

Microneedling Devices; Draft Guidance 

for Industry and Food and Drug 

Administration Staff; 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 the draft 

guidance entitled ‘‘Regulatory 

Considerations for Microneedling 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ This draft guidance is being 

issued to assist industry in 

understanding when a microneedling 

product is a device as defined in the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act). This draft guidance is 

not final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 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 

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–D–4792 for ‘‘Regulatory 

Considerations for Microneedling 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). An electronic copy of the 

guidance document is available for 

download from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Regulatory 

Considerations for Microneedling 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Peter Yang, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1551, Silver Spring, 

MD 20993–0002, 301–796–6477. 

SUPPLEMENTARY INFORMATION: 

I. Background 

‘‘Microneedling products’’ is a generic 

term that encompasses instruments with 

common technological features that 

include an array of needles, ‘‘microprotrusion’’ tips, or pins, which can be 

mstockstill on DSK30JT082PROD with NOTICES