52306 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. 

To comply with the above 

requirement, ACL is publishing a notice 

of a new collection of information as set 

forth in this document. With respect to 

the following collection of information, 

ACL invites comments on: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of ACL’s functions, including whether 

the information will have practical 

utility and/or help ACL illustrate the 

program’s return on investment; (2) the 

accuracy of ACL’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

when appropriate and other forms of 

information technology. 

Purpose 

The purpose of the Traumatic Brain 

Injury (TBI) State Partnership program 

is to increase access to rehabilitation 

and other services for individuals with 

traumatic brain injury. Under the 

Traumatic Brain Injury Reauthorization 

Act of 2014 (Pub. L. 113–196), the 

Traumatic Brain Injury State 

Partnership program transitioned from 

the Health Resources and Services 

Administration (HRSA) to the 

Administration for Community Living 

(ACL). Under this law, the Secretary, 

acting through ACL, was authorized to 

‘‘make grants to States and American 

Indian consortia for the purpose of 

carrying out projects to improve access 

to rehabilitation and other services 

regarding traumatic brain injury.’’ ACL 

seeks to collect performance measure 

data from state grantees consistent with 

the TBI State Partnership program’s 

purpose and ACL’s mission to 

‘‘Maximize the independence, wellbeing, and health of older adults, people 

with disabilities across the lifespan, and 

their families and caregivers.’’ 

ACL seeks data on a semi-annual 

basis on the types of practices, 

protocols, and activities performed by 

each grantee, as well as the cost of each 

activity and the number and types of 

people they served. ACL also seeks 

information about the number and types 

of individuals who receive TBI-related 

home and community based services. 

Finally, ACL seeks information 

regarding the involvement of people 

with TBI in advisory and program 

support roles. 

The data collected will allow ACL to 

determine the extent to which the grant 

program is meeting its goals of 

expanding and improving services, 

generating sustainable funding streams, 

and enriching service systems to better 

serve individuals with TBI and their 

families. The data will also help ACL 

develop and expand baseline 

information around the nature and 

scope of the incidence of TBI. 

Additionally, this data collection will 

help ACL illustrate the return on 

investment of the TBI funds in terms of 

system change (i.e., changes in policies 

and practices and the development of 

networks). By matching the project 

dollars spent against measurable 

improvements in state systems for 

delivering services and supports to 

people living with TBI, ACL will have 

a strong indicator of the effect of the TBI 

program on the quality of services 

which ultimately impact the lives of 

people across the country living with 

TBI. The proposed data collection forms 

may be found on the ACL Web site for 

review at: https://www.acl.gov/aboutacl/public-input. 

Estimated Program Burden: The 

annual reporting burden estimates are 

shown below. 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

States ............................ State Performance Report ................................... * 45 2 16 1,440 

* This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45 grants are awarded, the total burden 

hours will be adjusted proportionally. 

Dated: November 7, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–24525 Filed 11–9–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5138] 

S5(R3) Detection of Toxicity to 

Reproduction for Human 

Pharmaceuticals; International Council 

for Harmonisation; 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 a draft 

guidance entitled ‘‘S5(R3) Detection of 

Toxicity to Reproduction for Human 

Pharmaceuticals.’’ The draft guidance 

was prepared under the auspices of the 

International Council for Harmonisation 

(ICH), formerly the International 

Conference on Harmonisation. The draft 

guidance replaces the existing guidance 

entitled ‘‘S5(R2) Detection of Toxicity to 

Reproduction for Human 

Pharmaceuticals.’’ The draft guidance is 

intended to align with other ICH 

guidances, elaborate on concepts to 

consider when designing studies, and 

identify potential circumstances in 

which a risk assessment can be made 

based on preliminary studies. It also 

clarifies the qualification and potential 

use of alternative assays. 


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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 52307 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 12, 

2018. 

ADDRESSES: You may submit comments 

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 Office, 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–5138 for ‘‘S5(R3) Detection of 

Toxicity to Reproduction for Human 

Pharmaceuticals.’’ 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 Office. 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 this draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10001 

New Hampshire Ave., Hillandale 

Building, 4th Floor, Silver Spring, MD 

20993–0002, or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Abigail Jacobs, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6474, Silver Spring, 

MD 20993–0002, 301–796–0174; or 

Martin (Dave) Green, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3270, Silver Spring, MD 20993–0002, 

301–796–2640. Regarding the ICH: 

Amanda Roache, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1176, 

Silver Spring, MD 20993–0002, 301– 

796–4548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘S5(R3) Detection of Toxicity to 

Reproduction for Human 

Pharmaceuticals.’’ In recent years, 

regulatory authorities and industry 

associations have participated in many 

important initiatives to promote 

international harmonization of 

regulatory requirements. FDA has 

participated in several meetings 

designed to enhance harmonization and 

is committed to seeking scientifically 

based, harmonized technical procedures 

for pharmaceutical development. One of 

the goals of harmonization is to identify 

and reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products for human use 

among regulators around the world. The 

six founding members of the ICH are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labour, and Welfare; the 

Japanese Pharmaceutical Manufacturers 

Association; CDER and CBER, FDA; and 

the Pharmaceutical Research and 

Manufacturers of America. The 

Standing Members of the ICH 

Association include Health Canada and 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
52308 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 

Swissmedic. Any party eligible to 

become a member in accordance with 

the ICH Articles of Association can 

apply for membership in writing to the 

ICH Secretariat. The ICH Secretariat, 

which coordinates the preparation of 

documentation, operates as an 

international nonprofit organization and 

is funded by the members of the ICH 

Association. 

The ICH Assembly is the overarching 

body of the Association and includes 

representatives from each of the ICH 

members and observers. 

In August 2017, the ICH Assembly 

endorsed the draft guidance titled 

‘‘S5(R3) Detection of Toxicity to 

Reproduction for Human 

Pharmaceuticals’’ and agreed that the 

guidance should be made available for 

public comment. The draft guidance is 

the product of the S5(R3) Safety Expert 

Working Group of the ICH. Comments 

about this draft will be considered by 

FDA and the S5(R3) Safety Expert 

Working Group. 

The draft guidance replaces the 

existing guidance entitled ‘‘S5(R2) 

Detection of Toxicity to Reproduction 

for Human Pharmaceuticals.’’ The 

guidance has undergone major revisions 

to align with other ICH guidances, 

elaborate on concepts to consider when 

designing studies, and identify potential 

circumstances in which a risk 

assessment can be made based on 

preliminary studies. It also clarifies the 

qualification and potential use of 

alternative assays. 

To support using alternative assays, 

compounds that are either positive or 

negative in their ability to induce 

embryolethality or malformations are 

used in the process of qualifying the 

assays. Although a number of 

compounds have been identified in the 

draft guidance’s Annex, section 11.3.4, 

Tables 9–6 and 9–7, with the type of 

information for the compounds, the list 

is not complete; therefore, FDA is 

requesting data in the form of public 

comments to the docket for additional 

positive and negative reference 

compounds for potential inclusion into 

the list. These compounds can be either 

pharmaceuticals or nonpharmaceuticals and should be 

commercially available. For additional 

guidance, please refer to Endnote 3 in 

the S5(R3) guidance. This is not a 

request for data for the compounds 

already listed in Table 9–6, nor is this 

a request for examples of assays that 

could be used. 

This 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 ‘‘S5(R3) Detection of Toxicity to 

Reproduction for Human 

Pharmaceuticals.’’ 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. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://www.fda.gov/ 

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24483 Filed 11–9–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Voluntary 

Partner Surveys To Implement 

Executive Order 12862 in the Health 

Resources and Services 

Administration, OMB No. 0915–0212— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR must be 

received no later than January 12, 2018. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, 14N39, 5600 Fishers Lane, 

Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference, in compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995. 

Information Collection Request Title: 

Voluntary Partner Surveys to Implement 

Executive Order 12862 in the Health 

Resources and Services Administration 

OMB No. 0915–0212—Extension. 

Abstract: In response to Executive 

Order 12862, HRSA is proposing to 

conduct voluntary customer surveys of 

its partners to assess strengths and 

weaknesses in program services and 

processes. HRSA partners are typically 

state or local governments, health care 

facilities, health care consortia, health 

care providers, and researchers. HRSA 

is requesting continued approval for a 

generic clearance from OMB to conduct 

the partner surveys. 

Partner surveys to be conducted by 

HRSA might include, for example, mail 

or telephone surveys of grantees to 

determine satisfaction with grant 

processes or technical assistance 

provided by a contractor, or in-class 

evaluation forms completed by 

providers who receive training from 

HRSA grantees to measure satisfaction 

with the training experience. HRSA will 

use the results of these surveys to plan 

and redirect resources and efforts as 

needed to improve services and 

processes. 

HRSA may also use focus groups to 

gain partner input into the design of 

mail and telephone surveys. Focus 

groups, in-class evaluation forms, mail 

surveys, and telephone surveys are 

expected to be the preferred data 

collection methods. 

A generic approval allows HRSA to 

conduct a limited number of partner 

surveys without a full-scale OMB 

review of each survey. If this request 

receives continued approval, 

information on each individual partner 

survey will not be published in the 

Federal Register. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 


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