62628 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

In this data collection period, 85,000 

households will be screened. After 

determining eligibility and consent, 

12,500 respondents will complete the 

survey. The average burden per 

screened respondent remains at 3 

minutes, while the average burden per 

surveyed respondent is 25 minutes. The 

total estimated annualized burden hours 

are 9,458. 

The survey will be conducted among 

English or Spanish speaking male and 

female adults (18 years and older) living 

in the United States. There are no costs 

to respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Non-Participating Household (Screened) ....... NISVS Survey Instrument. First section nonparticipating.85,000 1 3/60 

Eligible Household ..........................................

(Completes Survey) ........................................

NISVS Survey Instrument. Section for participating.12,500 1 25/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–24879 Filed 10–17–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10398 and 

CMS–10529] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 

(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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by November 19, 

2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806, OR, Email: 

OIRA_s submission@omb.eop.gov. 

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’ Website address at 

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

PaperworkReductionActof1995. 

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: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Generic 

Clearance for Medicaid and CHIP State 

Plan, Waiver, and Program Submissions; 

Use: State Medicaid and CHIP agencies 

are responsible for developing 

submissions to CMS, including state 

plan amendments and requests for 

waivers and program demonstrations. 

States use templates when they are 

available and submit the forms to 

review for consistency with statutory 

and regulatory requirements (or in the 

case of waivers and demonstrations 

whether the proposal is likely to 

promote the objectives of the Medicaid 

program). If the requirements are met, 

we approve the states’ submissions 

giving them the authority to implement 

the flexibilities. For a state to receive 

Medicaid Title XIX funding, there must 

be an approved Title XIX state plan. 

The development of streamlined 

submissions forms enhances the 

collaboration and partnership between 

states and CMS by documenting our 

policy for states to use as they are 

developing program changes. 

Streamlined forms improve efficiency of 

administration by creating a common 

and user-friendly understanding of the 

information we need to quickly process 

requests for state plan amendments, 

waivers, and demonstration, as well as 

ongoing reporting. 

Form Number: CMS–10398 (OMB 

control number: 0938–1148); Frequency: 

Collection-specific, but generally the 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 62629 

frequency is yearly, once, and 

occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 56; Total Responses: 

1,540 (3-year total); Total Hours: 86,240 

(3-year total). (For policy questions 

regarding this collection contact 

Annette Pearson at 410–786–6858). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Quarterly 

Medicaid and CHIP Budget and 

Expenditure Reporting for the Medical 

Assistance Program, Administration and 

CHIP; Use: At the request of OMB, this 

action would consolidate the following 

three OMB control numbers for forms 

CMS–21 and –21B (OMB control 

number: 0938–0731), CMS–37 (OMB 

control number: 0938–0101), and CMS– 

64 (OMB control number: 0938–0067) 

into a single control number that will be 

assigned upon OMB approval. It is 

important to emphasize that the 

consolidation of the control numbers 

does not consolidate any of the forms 

required for Medicaid and CHIP Budget 

and Expenditure Reporting. 

While the overall package has been 

assigned a new CMS identification 

number (CMS–10529), the individual 

forms will retain their respective CMSspecific identification numbers, namely 

CMS–21, CMS–21B, CMS–37, and 

CMS–64. Supporting materials (see 

ADDRESSES) can be found under parent 

identification number, namely CMS– 

10529. 

This action also revises CMS–37 and 

–64 while CMS–21 and –21B remain 

unchanged. Forms CMS–21 and –21B 

provide CMS with the information 

necessary to issue quarterly grant 

awards, monitor current year 

expenditure levels, determine the 

allowability of state claims for 

reimbursement, develop Children’s 

Health Insurance Program (CHIP) 

financial management information, 

provide for state reporting of waiver 

expenditures, and ensure that the 

federally established allotment is not 

exceeded. They are also necessary in the 

redistribution and reallocation of 

unspent funds over the federally 

mandated timeframes. 

Form CMS–37 due dates are 

November 15, February 15, May 15 and 

August 15 of each fiscal year. While all 

submissions represent equally 

important components of the grant 

award cycle, the May and November 

submissions are particularly significant 

for budget formulation. The November 

submission introduces a new fiscal year 

to the budget cycle and serves as the 

basis for the formulation of the 

Medicaid portion of the President’s 

Budget, which is presented to Congress 

in January. The February and August 

submissions are used primarily for 

budget execution in providing interim 

updates to our Office of Financial 

Management, the Department of Health 

and Human Services, the Office of 

Management and Budget and Congress 

depending on the scheduling of the 

national budget review process in a 

given fiscal year. The submissions 

provide us with base information 

necessary to track current year 

obligations and expenditures in relation 

to the current year appropriation and to 

notify senior managers of any 

impending surpluses or deficits. 

Form CMS–64 is used to issue 

quarterly grant awards, monitor current 

year expenditure levels, determine the 

allowability of state claims for 

reimbursement, develop Medicaid 

financial management information 

provide for state reporting of waiver 

expenditures, ensure that the federallyestablished limit is not exceeded for 

HCBS waivers, and to allow for the 

implementation of the Assignment of 

Rights and Part A and Part B Premium 

(i.e., accounting for overdue Part A and 

Part B Premiums under state buy-in 

agreements)—Billing Offsets. 

Form Number: CMS–10529 (OMB 

control number: 0938—New); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 672; Total Annual 

Hours: 17,920. (For policy questions 

regarding this collection contact 

Abraham John at 410–786–4519). 

Dated: October 15, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–24862 Filed 10–17–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0161] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donor Testing, Donor Notification, and 

‘‘Lookback’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. 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 of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information 

requirements relating to FDA’s 

regulation of current good 

manufacturing practice (CGMP) and 

related regulations for blood and blood 

components; and requirements for 

donor testing, donor notification, and 

‘‘lookback.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 19, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in the brackets in 

the heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 


tkelley on DSK3SPTVN1PROD with NOTICES