9820 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 

668B (OMB# 0938–0653); Frequency: 

Biennially; Affected Public: Business or 

other for-profits and not-for-profit 

institutions. State, Local, or Tribal 

Government, Federal Government; 

Number of Respondents: 21,000; Total 

Annual Responses: 10,500; Total 

Annual Hours: 2,625. (For policy 

questions regarding this collection 

contact Kathleen Todd at 410–786– 

3385. 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 

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 April 6, 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: February 27, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–4791 Filed 3–5–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10165] 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Electronic 

Health Records (EHR) Demonstration 

Web Enabled Application for Phase II; 

Use: The goal of the Electronic Health 

Record (EHR) demonstration is to foster 

the implementation and adoption of 

EHRs and Health Information 

Technology (HIT) more broadly as 

effective vehicles improve the quality of 

care provided and transform the way 

medicine is practiced and delivered. 

Adoption of HIT has the potential to 

provide significant savings to the 

Medicare program and improve the 

quality of care rendered to Medicare 

beneficiaries. This demonstration is 

designed to leverage the combined 

forces of private and public payers to 

drive physician practices to widespread 

adoption and use of EHRs. The 

demonstration is being implemented in 

two phases. Over 800 applications were 

received, via a manual (paper) process, 

from interested practices in the four 

Phase I sites. Because of the greater 

number of sites and projected applicants 

for Phase II, CMS has Web enabled the 

application. This is expected to make it 

easier for practices to complete the 

application accurately and completely, 

submit it in a timely manner, and allow 

CMS to process the applications more 

efficiently and effectively. Form 

Number: CMS–10165(OMB#: 0938– 

0936–0965); Frequency: Reporting— 

Once; Affected Public: Business or other 

for-profit and not-for-profit institutions; 

Number of Respondents: 1,600; Total 

Annual Responses: 1,600; Total Annual 

Hours: 347. (For policy questions 

regarding this collection contact Jody 

Blatt at 410–786–6921. 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 May 5, 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 lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: February 27, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–4807 Filed 3–5–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0097] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Request for 

Samples and Protocols 

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 information collection requirements 

relating to the regulations which state 

that protocols for samples of biological 

products must be submitted to the 

agency. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 5, 2009. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 9821 

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 brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Request for Samples and Protocols 

(OMB Control Number 0910–0206)— 

Extension 

Under section 351 of the Public 

Health Service Act (42 U.S.C. 262), FDA 

has the responsibility to issue 

regulations that prescribe standards 

designed to ensure the safety, purity, 

and potency of biological products and 

to ensure that the biologics licenses for 

such products are only issued when a 

product meets the prescribed standards. 

Under § 610.2 (21 CFR 610.2), the 

Center for Biologics Evaluation and 

Research (CBER) or the Center for Drug 

Evaluation and Research may at any 

time require manufacturers of licensed 

biological products to submit to FDA 

samples of any lot along with the 

protocols showing the results of 

applicable tests prior to distributing the 

lot of the product. In addition to § 610.2, 

there are other regulations that require 

the submission of samples and protocols 

for specific licensed biological products: 

§§ 660.6 (21 CFR 660.6) (Antibody to 

Hepatitis B Surface Antigen); 660.36 (21 

CFR 660.36) (Reagent Red Blood Cells); 

and 660.46 (21 CFR 660.46) (Hepatitis B 

Surface Antigen). 

Section 660.6(a) provides 

requirements for the frequency of 

submission of samples from each lot of 

Antibody to Hepatitis B Surface Antigen 

product, and § 660.6(b) provides the 

requirements for the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.6 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After official release is no longer 

required, one sample along with a 

protocol is required to be submitted at 

90-day intervals. In addition, samples, 

which must be accompanied by a 

protocol, may at any time be required to 

be submitted to CBER if continued 

evaluation is deemed necessary. 

Section 660.36(a) requires, after each 

routine establishment inspection by 

FDA, the submission of samples from a 

lot of final Reagent Red Blood Cell 

product along with a protocol 

containing specific information. Section 

660.36(a)(2) requires that a protocol 

contain information including, but not 

limited to, manufacturing records, 

certain test records, and identity test 

results. Section 660.36(b) requires a 

copy of the antigenic constitution 

matrix specifying the antigens present 

or absent to be submitted to the CBER 

Director at the time of initial 

distribution of each lot. 

Section 660.46(a) contains 

requirements as to the frequency of 

submission of samples from each lot of 

Hepatitis B Surface Antigen product, 

and § 660.46(b) contains the 

requirements as to the submission of a 

protocol containing specific information 

along with each required sample. For 

§ 660.46 products subject to official 

release by FDA, one sample from each 

filling of each lot is required to be 

submitted along with a protocol 

consisting of a summary of the history 

of manufacture of the product, 

including all results of each test for 

which test results are requested by 

CBER. After notification of official 

release is received, one sample along 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of a product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 69 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2008, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 65 manufacturers 

submitted protocols under § 610.2 and 3 

manufacturers submitted protocols 

under the regulations (§§ 660.6 and 

660.46) for the other specific products. 

mstockstill on PROD1PC66 with NOTICES

9822 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 

FDA received no submissions under 

§ 660.36, however FDA is using the 

estimate of one protocol submission in 

the event one is submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2008, which totaled 

6,314, for the various submission 

requirements of samples and protocols 

for the licensed biological products. The 

rate of final actions is not expected to 

change significantly in the next few 

years. The hours per response are based 

on information provided by industry. 

The burden estimates provided by 

industry ranged from 1 to 5.5 hours. 

Under § 610.2, the hours per response 

are based on the average of these 

estimates and rounded to 3 hours. 

Under the remaining regulations, the 

hours per response are based on the 

higher end of the estimate (rounded to 

5 or 6 hours) since more information is 

generally required to be submitted in 

the other protocols than under § 610.2. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

610.2 65 95.5 6,208 3 18,624 

660.6(b) 2 44 88 5 440 

660.36(a)(2) and (b) 1 1 1 6 6 

660.46(b) 1 17 17 5 85 

Total 69 6,314 19,155 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: February 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4750 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0083] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Gluten-Free 

Labeling of Food Products 

Experimental Study 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a voluntary consumer study entitled 

‘‘Gluten-Free Labeling of Food Products 

Experimental Study.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by May 5, 2009. 

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 brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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 

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. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Gluten-Free Labeling of Food Products 

Experimental Study 

Under section 903(b)(2) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393(b)(2)), FDA is authorized to conduct 

research relating to foods and to 

conduct educational and public 

information programs relating to the 

safety of the nation’s food supply. FDA 

is planning to conduct an experimental 

study about gluten-free labeling of food 

products. The Gluten-Free Labeling of 

Food Products Experimental Study will 

collect information from both 

consumers who have celiac disease or 

gluten intolerance and those who do not 

have either condition. The purpose of 

the study is to gauge perceptions of 

characteristics related to claims of 

‘‘gluten-free’’ and allowed variants (e.g., 

‘‘free of gluten,’’ ‘‘without gluten,’’ ‘‘no 

gluten’’), in addition to other types of 

statements (e.g., ‘‘made in a gluten-free 

facility’’ or ‘‘not made in a facility that 

processes gluten-containing foods’’) on 

the food label. The study will also 

mstockstill on PROD1PC66 with NOTICES