41142 Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices 

Information Collection: National 

Medicare & You Education Program 

(NMEP) Survey of Medicare 

Beneficiaries Use: The Centers for 

Medicare and Medicaid Services is 

requesting a reinstatement of this 

information collection request to 

continue to collect information from 

Medicare beneficiaries, caregivers, 

health care providers, and health 

information providers. The collection of 

information was inadvertently 

discontinued in December 2008; 

however, as stated earlier, we are 

currently seeking a reinstatement with 

change as we have revised the collection 

instrument. It is critical for this agency 

to obtain feedback from the 

aforementioned groups so that the 

agency can accurately assess the needs 

of the Medicare audience. Using random 

digit dial and/or an administrative 

sample, members of the Medicare 

audience will be called and asked to 

complete the survey via telephone. The 

results of this survey will be compiled 

and studied so that communication may 

be amended to benefit Medicare’s 

audience. The survey has the following 

objectives: to assess satisfaction with 

and knowledge of the Medicare 

program; to gather information on 

health behaviors and quality of health 

care; to determine the most used source 

for Medicare information; and to gather 

information from health care provider 

and health information providers. Form 

Number: CMS–R–254 (OMB# 0938– 

0738); Frequency: Once; Affected 

Public: Individuals and Households, 

Private Sector—Business or other forprofits; Number of Respondents: 7,000; 

Total Annual Responses: 7,000; Total 

Annual Hours: 1,750. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

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

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on September 14, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: August 7, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–19537 Filed 8–13–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–284 and 

CMS–10190] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this 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. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicaid 

Statistical Information System; Use: 

State data are reported by the Federally 

mandated electronic process, known as 

(MSIS) Medical Statistical Information 

System. These data are the basis of 

actuarial forecasts for Medicaid service 

utilization and costs; of analysis and 

cost savings estimates required for 

legislative initiatives relating to 

Medicaid and for responding to requests 

for information from CMS components, 

the Department, Congress and other 

customers. 

Form Number: CMS–R–284 (OMB#: 

0938–0345); Frequency: Reporting— 

Quarterly; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 51; Total Annual 

Responses: 204; Total Annual Hours: 

2,040. (For policy questions regarding 

this collection contact Denise Franz 

410–786–6117. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Section 1901 of 

the Act (42 U.S.C. 1396) requires that 

States must establish a State plan for 

medical assistance that are approved by 

the Secretary to carry out the purposes 

of title XIX. The DRA provides States 

with numerous flexibilities in operating 

their State Medicaid programs. The 

intent of these flexibilities is to provide 

States with program alternatives that 

allow them to provide the most 

appropriate health care coverage that 

meets beneficiary needs, while at the 

same time curtailing State and Federal 

spending. Except for the documentation 

of citizenship requirements, States can 

submit SPAs to CMS to effectuate these 

changes to their Medicaid programs. 

CMS provided State Medicaid Directors 

letters providing guidance on these 

provisions and the implementation of 

the DRA and associated SPA templates 

for use by States to modify their 

Medicaid State plans if they choose to 

implement these flexibilities. Under this 

process, the end result is the State 

burden will be reduced significantly. To 

implement these flexibilities, a 

collection of information to effectuate 

these changes is required. Therefore, 

State Medicaid agencies will complete 

the templates to effectuate the changes. 

CMS will review the information to 

determine if the State has met all of the 

requirements of the DRA provisions the 

States choose to implement. If the 

requirements are met, CMS will approve 

the amendments to the State’s Title XIX 

plan giving the State the authority to 

implement the flexibilities. For a State 

to receive Medicaid Title XIX funding, 

there must be an approved Title XIX 

State plan. Five templates were created 

to assist States in effectuating these 

flexibilities through modifications to the 

State plan. The Children’s Health 

Insurance Program Reauthorization Act 

(CHIPRA) of 2009, enacted on February 

4, 2009, corrected language in section 

6044 (Alternative Benefit Packages) of 

the DRA as if these amendments were 

included in the DRA, and subsequently 

amended section 1937 ‘‘State Flexibility 

for Medicaid Benefit Packages.’’ We 

have modified the preprints to reflect 

these statutory changes. Form Number: 

CMS–10190 (OMB#: 0938–0993); 

Frequency: Reporting—Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 16; Total 

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Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices 41143 

Annual Hours: 699. (For policy 

questions regarding this collection 

contact Fran Crystal at 410–786–1195. 

For all other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

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

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by October 13, 2009: 

1. Electronically. You may submit 

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) 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 (CMS–R–284 and 

CMS–10190), Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: August 7, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–19539 Filed 8–13–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0342] 

International Conference on 

Harmonisation; Draft Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex 10 on 

Polyacrylamide Gel Electrophoresis 

General Chapter; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Q4B Evaluation and Recommendation 

of Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 10: Polyacrylamide 

Gel Electrophoresis General Chapter.’’ 

The draft guidance was prepared under 

the auspices of the International 

Conference on Harmonisation of 

Technical Requirements for Registration 

of Pharmaceuticals for Human Use 

(ICH). The draft guidance provides the 

results of the ICH Q4B evaluation of the 

Polyacrylamide Gel Electrophoresis 

General Chapter harmonized text from 

each of the three pharmacopoeias 

(United States, European, and Japanese) 

represented by the Pharmacopoeial 

Discussion Group (PDG). The draft 

guidance conveys recognition of the 

three pharmacopoeial methods by the 

three ICH regulatory regions and 

provides specific information regarding 

the recognition. The draft guidance is 

intended to recognize the 

interchangeability between the local 

regional pharmacopoeias, thus avoiding 

redundant testing in favor of a common 

testing strategy in each regulatory 

region. This draft guidance is the tenth 

annex to the core Q4B guidance, which 

was made available in the Federal 

Register of February 21, 2008 (73 FR 

9575). 

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 

written or electronic comments on the 

draft guidance by October 13, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002; or the Office of 

Communication and Development 

(HFM–40), Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852– 

1448. The guidance may also be 

obtained by mail by calling the Center 

for Biologics Evaluation and Research at 

1–800–835–4709 or 301–827–1800. 

Send two self-addressed adhesive labels 

to assist the office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242; or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, Suite 200N, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many 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 then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite 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 among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

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