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endorsed the draft guidance titled 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 The draft guidance is 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The draft guidance replaces the 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draft guidance’s Annex, section 11.3.4, 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This draft guidance is being issued 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 52309 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

In-class evaluations ............................................................. 40,000 1 40,000 .05 2,000 

Mail/Telephone surveys ....................................................... 12,000 1 12,000 .25 3,000 

Focus groups ....................................................................... 250 1 250 1.5 375 

Total .............................................................................. 52,250 ........................ 52,250 ........................ 5,375 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Amy McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2017–24492 Filed 11–9–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Assessing Client Factors 

Associated With Detectable HIV Viral 

Loads; and Models of Care and the 

Ryan White HIV/AIDS Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than December 13, 

2017. 

ADDRESSES: Submit your comments, 

including the ICR Title, to the desk 

officer for HRSA, either by email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Assessing Client Factors Associated 

with Detectable HIV Viral Loads and 

Models of Care and the Ryan White 

HIV/AIDS Program. 

OMB No.: 0906–xxxx—NEW. 

Abstract: The Ryan White HIV/AIDS 

Program (RWHAP), first authorized by 

the U.S. Congress in 1990, is 

administered by HRSA’s HIV/AIDS 

Bureau (HAB). The RWHAP provides 

medical services, treatment, and/or 

support services to 533,036 clients in 

2015; 97.0 percent of these clients were 

living with HIV. This information 

collection request covers two distinct 

evaluation studies with RWHAP 

provider sites that will share 

components of data collection 

instruments through shared variables. 

Sharing data collection instruments will 

minimize burden for RWHAP provider 

sites collecting this data and will 

increase the sample size for data 

analysis thus resulting in more robust 

data and greater generalizability of 

results. 

The first evaluation study, Assessing 

Client Factors Associated with 

Detectable HIV Viral Loads, will explore 

individuals’ specific facilitators and 

barriers to achieving and sustaining 

viral suppression. Early and effective 

treatment for HIV has been shown to 

greatly reduce associated morbidity and 

mortality, and prevents transmission of 

HIV. In spite of the known benefit of 

treatment, many individuals remain out 

of care or access care only 

intermittently; the CDC estimated that 

in 2013, approximately 45 percent of 

people living with HIV (PLWH) in the 

United States were not virally 

suppressed, indicating a significant gap 

in the percentage of PLWH who are 

being successfully engaged and retained 

in care. In spite of the increased 

attention on retention in care and the 

overarching goal of viral suppression, 

little data exist regarding the specific 

individual factors that are associated 

with sub-optimal viral suppression. 

Such information is valuable for 

targeting programs to reach populations 

that are currently not achieving HIV 

viral suppression. 

The second evaluation study, Models 

of Care and the Ryan White HIV/AIDS 

Program, seeks to answer the critical 

questions of what individual and 

system-wide factors, including the 

models of care employed among 

RWHAP provider sites, contribute to 

better health outcomes for PLWH. While 

advances in treatment have improved 

survival in patients with HIV, longer 

lives are associated with increased 

prevalence of adverse effects of HIV 

infection and therapeutic complications, 

concurrent with medical conditions 

related to aging processes that would 

occur in the absence of HIV. These longterm complications amplify chronic 

disease management as a major issue for 

the HIV population and a challenge for 

the delivery of effective health care. Yet 

little is known about how the method of 

health services delivery (the ‘‘model of 

care’’) contributes to better health 

outcomes, including HIV-related 

outcomes. For example, does it make a 

difference if a patient receives HIV care 

from a primary care provider, a 


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