46432 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 

Estimated Annual Reporting Burden for 

Biological Products in the Center for 

Biologics Evaluation and Research 

Under § 312.23(a)(7)(iv)(e) and 

601.2(a), INDs and BLAs must contain a 

claim for categorical exclusion under 

§ 25.30 or § 25.31 or an EA under 

§ 25.40. In 2008, FDA received 245 INDs 

from 180 sponsors, 28 BLAs from 13 

applicants, and 972 BLA supplements to 

license applications from 173 

applicants. FDA estimates that 

approximately 10 percent of these 

supplements would be submitted with a 

claim for categorical exclusion or an EA. 

FDA estimates that it received 

approximately 370 claims for categorical 

exclusion as required under § 25.15(a) 

and (d), and 2 EAs as required under 

§ 25.40(a) and (c). Based on information 

provided by industry, FDA estimates 

that it takes sponsors and applicants 

approximately 8 hours to prepare a 

claim for categorical exclusion and 

approximately 3,400 hours to prepare an 

EA for a biological product. 

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

25.15(a) and (d) 210 1 .76 370 8 2,960 

25.40(a) and (c) 2 1 2 3,400 6,800 

Total 9,760 

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

Estimated Annual Reporting Burden for 

Animal Drugs 

Under 21 CFR 514.1(b)(14), new 

animal drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs); 21 CFR 

514.8(a)(1) supplemental NADAs and 

ANADAs; 21 CFR 511.1(b)(10) 

investigational new animal drug 

applications (INADs); and 21 CFR 

571.1(c) food additive petitions must 

contain a claim for categorical exclusion 

under § 25.30 or § 25.33 or an EA under 

§ 25.40. In 2008, FDA’s Center for 

Veterinary Medicine received 

approximately 676 claims for categorical 

exclusion as required under § 25.15(a) 

and (d), and 8 EAs as required under 

§ 25.40(a) and (c). FDA estimates that it 

takes sponsors/applicants 

approximately 5 hours to prepare a 

claim for a categorical exclusion and an 

average of 2,160 hours to prepare an EA. 

TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

25.15(a) and (d) 65 10.4 676 5 3,380 

25.40(a) and (c) 6 1.3 8 2,160 17,280 

Total 20,660 

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

TABLE 6.—COMBINED ESTIMATED ANNUAL TOTAL BURDEN HOURS FOR ALL CENTERS

Total 193,797 

Dated: August 28, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21724 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10295] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

Medicaid Services, Department of 

Health and Human Services. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS), Department of Health 

and Human Services, 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. 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 46433 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

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

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting emergency approval 

under 5 CFR 1320.13(a)(2)(iii), as we 

believe that the use of normal clearance 

procedures is reasonably likely to cause 

a statutory deadline to be missed for 

annual reports to Congress as required 

under sections 5001 and 5004 of the 

Recovery Act. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Recovery Act— 

Reporting Requirements for States 

Under FMAP Increase and TMA 

Provisions; Use: The American 

Recovery and Reinvestment Act of 2009 

(Recovery Act), Public Law 111–5, 

requires that States submit quarterly 

reports to the Secretary of Health and 

Human Services in accordance with 

section 5001 Temporary Increase of 

Medicaid Federal Medical Assistance 

Percentage (FMAP) and section 5004(d) 

Extension of Transitional Medical 

Assistance (TMA). The reports under 

section 5001 are required for the period 

of October 1, 2008–September 30, 2011. 

The reports under section 5004 are 

required beginning on July 1, 2009 until 

the Federal authority for TMA coverage 

sunsets (now scheduled to sunset on 

December 31, 2010). Each State 

Medicaid agency will submit its 

quarterly reports to the appropriate 

Regional Office of CMS. The reports will 

be compiled and summarized for annual 

reports to Congress. Form Number: 

CMS–10295 (OMB#: 0938–New); 

Frequency: Reporting—Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

50; Total Annual Responses: 200; Total 

Annual Hours: 600. (For policy 

questions regarding this collection 

contact Richard Strauss at 410–786– 

2019. For all other issues call 410–786– 

1326.) 

CMS is requesting OMB review and 

approval of this collection by October 5, 

2009, with a 180-day approval period. 

Written comments and recommendation 

will be considered from the public if 

received by the individuals designated 

below by the noted deadline below. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s 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. 

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 9, 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–10295), Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

and, 

OMB Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, New Executive Office Building, 

Room 10235, Washington, DC 20503. 

Fax Number: (202) 395–6974. 

Dated: August 31, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–21674 Filed 9–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0386] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection or Detection 

and Differentiation of Human 

Papillomaviruses; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection or Detection 

and Differentiation of Human 

Papillomaviruses.’’ FDA is issuing this 

draft guidance to inform industry and 

agency staff of its recommendations for 

analytical and clinical performance 

studies to support premarket 

submissions for in vitro diagnostic 

devices intended for the detection or 

detection and differentiation of human 

papillomaviruses. 

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 December 8, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection or 

Detection and Differentiation of Human 

Papillomaviruses’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–847–8149. See the 

SUPPLEMENTARY INFORMATION 

section for information on electronic 

access to the guidance. 

Submit written comments concerning 

this 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Kate 

Simon, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5552, Silver Spring, 

MD 20993, 301–796–6204. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document 

recommends studies that may be used to 

establish the analytical and clinical 

performance of in vitro diagnostic 

devices (IVDs) for the detection or 

detection and differentiation of human 

papillomaviruses (HPV) in cervical 

specimens. This guidance is limited to 

studies intended to establish the 

performance characteristics of in vitro 

diagnostic HPV devices that are used in 

conjunction with cervical cytology for 

cervical cancer screening. It does not 


cprice-sewell on DSK2BSOYB1PROD with NOTICES