51276 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10291] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

January 2, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ____, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10291 State Collection and 

Reporting of Dental Provider and 

Benefit Package Information on the 

Insure Kids Now! Web site and 

Hotline 

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. 

The term ‘‘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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Collection 

and Reporting of Dental Provider and 

Benefit Package Information on the 

Insure Kids Now! Web site and Hotline; 

Use: On the Insure Kids Now (IKN) Web 

site, the Secretary is required to post a 

current and accurate list of dentists and 

providers that provide dental services to 

children enrolled in the state plan (or 

waiver) under Medicaid or the state 

child health plan (or waiver) under 

CHIP. States collect the information 

pertaining to their Medicaid and CHIP 

dental benefits. Form Number: CMS– 

10291 (OMB control number: 0938– 

1065); Frequency: Yearly and quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

51; Total Annual Responses: 255; Total 

Annual Hours: 11,781. (For policy 

questions regarding this collection 

contact Andrew Snyder at 410–786– 

1274.) 

Dated: October 31, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–24013 Filed 11–2–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Culture of Continuous Learning 

Project: A Breakthrough Series 

Collaborative for Improving Child Care 

and Head Start Quality. 

OMB No.: New Collection. 

Description: The Office of Planning, 

Research and Evaluation (OPRE) in the 

Administration for Children and 

Families (ACF) is proposing an 

information collection activity for the 

Culture of Continuous Learning Project. 

The goal of the project is to assess the 

feasibility of implementing continuous 

quality improvement methods in early 

care and education programs to support 

the use and sustainability of evidencebased practices. A Breakthrough Series 

Collaborative (BSC), a specific model 

designed to support learning and 

improvement among practitioners at all 

levels of an organization, will be 

implemented in Head Start and child 

care settings. The BSC methodology has 

not been tested rigorously in early care 

and education programs, but has been 

studied in health care and other fields. 

The findings will be of broad interest to 

child care early education programs as 

well as training and technical assistance 

providers and researchers, all of whom 

are interested in improving the quality 

of services young children receive. 

Head Start and child care programs 

that voluntarily participate in the BSC 

will be asked to complete a number of 

implementation tools as part of the BSC 

activities. Data collection for the 

feasibility study will involve focus 


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Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51277 

groups, online surveys, direct 

observation, and document review. 

Respondents: Up to 18 early 

childhood centers will be invited to 

express interest in participating in the 

BSC. Up to 8 centers will be selected to 

participate in the BSC and feasibility 

study. Core BSC Teams consisting of up 

to 6 individuals (e.g., directors, lead 

teachers, assistant teachers, teacher 

aides, parents, curriculum specialists, 

etc.) each from four Early Head Start or 

Head Start programs and four child care 

programs in a selected geographic 

location (for a total of 48 individuals); 

and up to 24 additional teachers or 

program staff at the same centers who 

are not part of the Core BSC Team. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

BSC Selection Questionnaire ............................................ 18 9 1 1 9 

Pre-Work Assignment: Team Building Activities ............... 48 24 1 1 24 

Pre-Work Assignment: Data Collection Planning Worksheet ............................................................................... 16 8 1 2 16 

Plan, Do, Study, Act Planning Form & Tracker ................. 48 24 48 .25 288 

Discussion Forum Prompts ................................................ 48 24 48 .25 288 

Learning Session Day 1 Evaluation .................................. 48 24 4 .17 16 

Learning Session Overall Evaluation ................................. 48 24 4 .25 24 

Action Planning Form ........................................................ 48 24 4 .25 24 

Teaching Pyramid Observation Tool (TPOT)/Teaching 

Pyramid Infant-Toddler Observation Scale (TPITOS) ... 28 14 2 .33 9 

Early Childhood Work Environment Survey (ECWES) ..... 72 36 2 .25 18 

Pre/Post Survey ................................................................. 72 36 2 .68 49 

Self-report of BSC Activities .............................................. 72 36 1 .17 6 

Core BSC Team Focus Group Topic Guide ..................... 48 24 1 1 .25 30 

Estimated Total Annual Burden 

Hours: 801. 

Additional Information: Copies of the 

proposed collection 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, 

Attn: OPRE Reports Clearance Officer. 

All requests should be identified by the 

title of the information collection. Email 

address: OPREinfocollection@

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 Certifying Officer. 

[FR Doc. 2017–23970 Filed 11–2–17; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1147] 

Controlled Correspondence Related to 

Generic Drug Development; 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 for industry entitled 

‘‘Controlled Correspondence Related to 

Generic Drug Development.’’ This 

guidance provides information 

regarding the process by which generic 

drug manufacturers and related industry 

can submit controlled correspondence 

to FDA requesting information related to 

generic drug development and the 

Agency’s process for providing 

communications related to such 

correspondence. This guidance also 

describes the process by which generic 

drug manufacturers and related industry 

can submit requests to clarify 

ambiguities in FDA’ controlled 

correspondence response and the 

Agency’s process for responding to 

those requests. This draft guidance 

revises the guidance for industry 

‘‘Controlled Correspondence Related to 

Generic Drug Development’’ issued in 

September 2015. 

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 January 2, 

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 


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