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
46434 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 

address HPV devices that are intended 

to be used independent of a cervical 

cytology result. 

The one product code established for 

this HPV DNA detection device is code 

MAQ, class III. The recommendations in 

this guidance apply to HPV diagnostic 

devices that detect HPV nucleic acid 

(not only HPV DNA, but HPV RNA, as 

well). Many of the recommendations 

will also apply to HPV detection devices 

that utilize targets other than HPV 

nucleic acid (such as HPV protein). This 

guidance therefore may encompass 

future HPV product codes beyond the 

one listed. Because HPV diagnostic 

devices are postamendment devices, 

they are automatically classified as class 

III under section 513(f)(1) of the Federal 

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

360c(f)(1)). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on establishing the performance 

characteristics of in vitro diagnostic 

devices for the detection or detection 

and differentiation of human 

papillomaviruses. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Establishing 

the Performance Characteristics of In 

Vitro Diagnostic Devices for the 

Detection or Detection and 

Differentiation of Human 

Papillomaviruses,’’ you may either send 

an e-mail request to dsmica@fda.hhs.gov 

to receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1699 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance documents. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 814 have been approved 

under OMB Control No. 0910–0231; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB Control No. 0910–0078; and the 

collections of information in 21 CFR 

809.10 have been approved under OMB 

Control No. 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: August 26, 2009. 

Catherine M. Cook, 

Associate Director for Regulations and Policy. 

[FR Doc. E9–21725 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0260] 

Guidance for Industry: Questions and 

Answers Regarding the Reportable 

Food Registry as Established by the 

Food and Drug Administration 

Amendments Act of 2007; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Questions and Answers 

Regarding the Reportable Food Registry 

as Established by the Food and Drug 

Administration Amendments Act of 

2007.’’ The document provides 

guidance to the industry in complying 

with the Reportable Food Registry 

requirements prescribed by the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA). 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Food Defense, Communication 

and Emergency Response (HFS–005), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Faye 

Feldstein, Center for Food Safety and 

Applied Nutrition (HFS–005), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 1–888– 

SAFEFOOD. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2009 (74 FR 27803), FDA announced the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Reportable Food Registry as Established 

by the Food and Drug Administration 

Amendments Act of 2007’’ and gave 

interested parties an opportunity to 

submit comments by July 27, 2009. The 

agency reviewed and evaluated these 

comments and has modified the 

guidance where appropriate. 

The guidance contains questions and 

answers intended to assist those parties 

responsible for complying with the 

Reportable Food Registry requirements 

prescribed by the Food and Drug 

Administration Amendments Act of 

2007 (Public Law 110–085), including: 

(1) How, when, and where to submit 

reports to FDA; (2) who is required to 

submit reports to FDA; (3) what is 

required to be submitted to FDA; and (4) 

what may be required when providing 

notifications to other persons in the 

supply chain of an article of food. 


cprice-sewell on DSK2BSOYB1PROD with NOTICES