Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices 43887 

Healthy Communities activities that 

were part of the original information 

collection request. 

CDC will continue to collect 

information about each awardee’s 

tobacco control objectives, planning, 

activities, resources, partnerships, 

strategies, and progress toward meeting 

objectives. Awardees will use the 

information reported through the 

electronic MIS to manage and 

coordinate their activities and to 

improve their efforts. CDC will use the 

information reported through the MIS to 

document and monitor each awardee’s 

progress and to make adjustments, as 

needed, in the type and level of 

technical assistance provided to them. 

The information collection allows CDC 

to oversee the use of federal funds, and 

identify and disseminate information 

about successful strategies implemented 

by awardees. CDC also uses the 

information to respond to Congressional 

and stakeholder inquiries about awardee 

activities, program implementation, and 

program impact. 

Progress reporting through the MIS is 

required for DP09–901 awardees. There 

are no costs to respondents other than 

their time. 

Estimated Annualized Burden Hours 

Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

State Tobacco Control Program ...................................................................... 53 2 6 636 

Kimberly S. Lane, 

Deputy Director, Office of Scientific Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2013–17525 Filed 7–19–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10493 and CMS– 

10495] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid 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 

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 must be received by 

September 20, 2013. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). 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/ 

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: 

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–10493 Nationwide Consumer 

Assessment of Healthcare Providers 

and Systems (DCAHPS) Survey for 

Adults in Medicaid 

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 

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 Collections 

1. Type of Information Collection 

Request: New collection (request for a 

new OMB control number); Title of 

Information Collection: Nationwide 

Consumer Assessment of Healthcare 

Providers and Systems (DCAHPS) 

Survey for Adults in Medicaid; Use: The 

goal of the survey is to attain national 

and state-by-state estimates of adult 

Medicaid beneficiaries’ access and 

experiences and satisfaction with care 


tkelley on DSK3SPTVN1PROD with NOTICES
43888 Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices 

across different financing and delivery 

models (e.g., managed care and fee-forservice) and population groups (e.g., 

beneficiaries with physical, mental or 

both physical and mental disabilities, 

dually eligible beneficiaries, all other 

beneficiaries). The survey will serve as 

baseline information on the experiences 

of low-income adults during the early 

stages of implementation of the 

Affordable Care Act provision that 

permits states to expand eligibility to 

adults with income below 138 percent 

of the federal poverty level who were 

not previously eligible. Along with 

states, we can use the survey 

information as one indicator of the 

quality of care within and across states. 

It also will be used to assist us along 

with the states in efforts to provide 

better care and more affordable care to 

Medicaid beneficiaries. Form Number: 

CMS–10493 (OCN: 0938–New); 

Frequency: Once; Affected Public: 

Individuals and households; Number of 

Respondents: 1,500,000; Total Annual 

Responses: 510,000. Total Annual 

Hours: 170,000. (For policy questions 

regarding this collection contact Marsha 

Lillie-Blanton at 410–786–8856.). 

2. Type of Information Collection 

Request: New collection (request for a 

new OMB control number); Title of 

Information Collection: Registration, 

Attestation, Dispute & Resolution, 

Assumptions Document and Data 

Retention Requirements for Open 

Payments; Use: Section 6002 of the 

Affordable Care Act added section 

1128G to the Social Security Act (Act), 

which requires applicable 

manufacturers and applicable group 

purchasing organizations (GPOs) of 

covered drugs, devices, biologicals, or 

medical supplies to report annually to 

CMS certain payments or other transfers 

of value to physicians and teaching 

hospitals, as well as, certain information 

regarding the ownership or investment 

interests held by physicians or their 

immediate family members in 

applicable manufacturers or applicable 

GPOs. 

Specifically, applicable manufacturers 

of covered drugs, devices, biologicals, 

and medical supplies are required to 

submit on an annual basis the 

information required in section 

1128G(a)(1) of the Act about certain 

payments or other transfers of value 

made to physicians and teaching 

hospitals (collectively called covered 

recipients) during the course of the 

preceding calendar year. Similarly, 

section 1128G(a)(2) of the Act requires 

applicable manufacturers and 

applicable GPOs to disclose any 

ownership or investment interests in 

such entities held by physicians or their 

immediate family members, as well as 

information on any payments or other 

transfers of value provided to such 

physician owners or investors. 

Applicable manufacturers must report 

the required payment and other transfer 

of value information annually to CMS in 

an electronic format. The statute also 

provides that applicable manufacturers 

and applicable GPOs must report 

annually to CMS the required 

information about physician ownership 

and investment interests, including 

information on any payments or other 

transfers of value provided to physician 

owners or investors, in an electronic 

format by the same date. Applicable 

manufacturers and applicable GPOs are 

subject to civil monetary penalties 

(CMPs) for failing to comply with the 

reporting requirements of the statute. 

We are required by statute to publish 

the reported data on a public Web site. 

The data must be downloadable, easily 

searchable, and aggregated. In addition, 

we must submit annual reports to the 

Congress and each state summarizing 

the data reported. Finally, section 

1128G of the Act generally preempts 

state laws that require disclosure of the 

same type of information by 

manufacturers. 

We published a final rule in 2013 to 

implement this program, which 

included several information collections 

subject to the Paperwork Reduction Act. 

This information collection request is to 

inform the public about information 

collected that is necessary for 

registration, attestation, dispute 

resolution and corrections, record 

retention, and submitting an 

assumptions document within Open 

Payments. Form Number: CMS–10495 

(OCN: 0938–New); Frequency: Once; 

Affected Public: Private sector— 

Business or other for-profits; Number of 

Respondents: 451,582; Total Annual 

Responses: 451,582. Total Annual 

Hours: 949,005. (For policy questions 

regarding this collection contact Melissa 

Heesters at 410–786–0618.). 

Dated: July 16, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–17476 Filed 7–19–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0838] 

Compliance Policy Guide Sec. 

253.100—Use of Units of Plasma and 

Fresh Frozen Plasma Which Have 

Been Thawed; Withdrawal of 

Compliance Policy Guide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of the compliance policy 

guide (CPG) entitled ‘‘Sec. 253.100—Use 

of Units of Plasma and Fresh Frozen 

Plasma Which Have Been Thawed,’’ 

issued October 1, 1980, and revised in 

March 1995. 

DATES: The withdrawal is effective July 

22, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Robert L. Hummel, Medical Products 

and Tobacco Policy Staff, Office of 

Policy and Risk Management, Office of 

Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 301–796–4510. 

SUPPLEMENTARY INFORMATION: FDA 

issued the CPG entitled ‘‘Sec. 253.100— 

Use of Units of Plasma and Fresh Frozen 

Plasma Which Have Been Thawed’’ on 

October 1, 1980, and revised it in March 

1995. FDA originally issued CPG Sec. 

253.100 to provide FDA’s current 

thinking regarding the time limits for 

when thawed frozen plasma should be 

used for transfusion. At the time of 

issuance of the CPG, 21 CFR 

606.122(m)(3) provided that the 

instruction circular shall include, when 

applicable, instructions to begin 

administration of the product within 6 

hours after thawing. The CPG noted a 

planned regulatory change that would 

allow greater flexibility in the time of 

administration requirements for frozen 

plasma products. 

In a final rule published in the 

Federal Register on January 3, 2012 (77 

FR 7), with an effective date of July 2, 

2012, FDA modified the time limits 

contained in the instruction circular for 

when administration of thawed frozen 

plasma products begins, as required by 

21 CFR 606.122(m)(3), to ‘‘within a 

specified time after thawing.’’ As noted 

in the preamble to the final rule, the 

change was made ‘‘to provide industry 

with increased flexibility for developing 

and specifying timeframes for which 

thawed plasma components can still be 

used for transfusion if stored at 


tkelley on DSK3SPTVN1PROD with NOTICES