Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9005 

costs associated with compliance for 

these entities are negligible. 

William Blumenthal, 

General Counsel. 

[FR Doc. E7–3397 Filed 2–27–07; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Scientific, Technical 

and Operational Services for 

Epidemiology, Surveillance and 

Laboratory Program, Contract 

Solicitation Number (CSN) 2006–N–

08556 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces a meeting of the 

aforementioned Special Emphasis 

Panel. 

Time And Date: 12 p.m.–3 p.m., 

March 21, 2007 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in section 552b(c)(4) 

and (6), Title 5 U.S.C., and the 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92–

463. 

Matters To Be Discussed: The meeting 

will include the review, discussion, and 

evaluation of the scientific merit of 

research applications in response to 

CSN 2006–N–08556, ‘‘Scientific, 

Technical and Operational Services for 

Epidemiology, Surveillance and 

Laboratory Program.’’

Contact Person For More Information: 

Christine Morrison, PhD., Designated 

Federal Officer, 1600 Clifton Road, 

Mailstop D72, Atlanta, GA 30333, 

telephone (404) 639–3098. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–3470 Filed 2–27–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0425] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 30, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance: 

Premarket Notification—21 CFR Part 

807; Subpart E—(OMB Control Number 

0910–0120)—Extension 

Section 510(k) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360(k)) and the implementing 

regulation under part 807 (21 CFR part 

807, subpart E) require a person who 

intends to market a medical device to 

submit a premarket notification 

submission to FDA at least 90 days 

before proposing to begin the 

introduction, or delivery for 

introduction into interstate commerce, 

for commercial distribution of a device 

intended for human use. Based on the 

information provided in the 

notification, FDA must determine 

whether the new device is substantially 

equivalent to a legally marketed device, 

as defined in § 807.92(a)(3). If the device 

is determined to be not substantially 

equivalent to a legally marketed device, 

it must have an approved premarket 

approval application (PMA), Product 

Development Protocol or be reclassified 

into Class I or Class II before being 

marketed. The FDA makes the final 

decision of whether a device is 

equivalent or not equivalent. 

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(Public Law 107–250) added section 

510(o) to the act to establish new 

regulatory requirements for reprocessed 

single-use devices (SUDs). MDUFMA 

was signed into law on October 26, 

2002. 

Section 510(o) of the act requires that 

FDA review the types of reprocessed 

SUDs subject to premarket notification 

requirements and identify which of 

these devices require the submission of 

validation data to ensure their 

substantial equivalence to predicate 

devices. Section 510(o) also requires 

that FDA review critical and semicritical reprocessed SUDs that are 

currently exempt from premarket 

notification requirements and determine 

which of these devices require the 

submission of premarket notifications to 

ensure their substantial equivalence to 

predicate devices. 

FDA has identified the reprocessed 

SUDs that require the submission of 

validation data to date. The requirement 

to submit validation data for certain 

reprocessed single-use devices has been 

incorporated into the premarket 

notification program. As with all other 

devices, new premarket notifications for 

reprocessed SUDs will be required as 

new manufacturers enter the market or 

manufacturers with cleared premarket 

notifications make significant changes 

to their device. The burden estimates in 

this document include the burden for 

submitting premarket notifications for 

reprocessed SUDs with the burden for 

all other devices. FDA may amend the 

lists of reprocessed SUDs that require 

the submission of premarket 

notifications with validation data as 

necessary. 

Section 807.81 states when a 

premarket notification is required. A 

premarket notification is required to be 

submitted by a person who is: 

• Introducing a device to the market 

for the first time; 

• Introducing or reintroducing a 

device which is significantly changed or 

modified in design, components, 

method of manufacturer, or the 

intended use that could affect the safety 

and effectiveness of the device. 

Section 807.87 specifies information 

required in a premarket notification 

submission. 

Section 204 of the Food and Drug 

Administration Modernization Act 


sroberts on PROD1PC70 with NOTICES
9006 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

(FDAMA) amended section 514 of the 

act (21 U.S.C. 360d). Amended section 

514 allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions including 

premarket notifications or other 

requirements. FDA has published and 

updated the list of recognized standards 

regularly since enactment of FDAMA 

and has allowed 510(k) submitters to 

certify conformance to recognized 

standards to meet the requirements of 

§ 807.87. Certification of conformance to 

a recognized standard may allow a 

manufacturer to submit an abbreviated 

510(k). FDA is now seeking approval of 

a form (Form FDA 3654) that will 

standardize certification of conformance 

to a recognized standard. FDA believes 

that use of this form will simplify the 

certification process for 510(k) 

submitters and the review process for 

FDA. 

Form FDA 3514, a summary cover 

sheet form, has been created to assist 

respondents in categorizing 510(k) 

information for submission to FDA. This 

form also assists respondents in 

categorizing information for other FDA 

medical device programs such as PMAs, 

investigational device exemptions, and 

humanitarian device exemptions The 

total burden (1,000 hours) for Form FDA 

3514 has been included in this 

information collection. Form FDA 3654 

is used in the following information 

collections: 0910–0078, 0910–0231, and 

0910–0332, but the burden is approved 

under this information collection (0910–

0120). 

Under § 807.87(h), each 510(k) 

submitter must include in the 510(k) 

either a summary of the information in 

the 510(k) (510(k) summary) or a 

statement certifying that the submitter 

will make available upon request the 

information in the 510(k) (510(k) 

statement). If the 510(k) submitter 

includes a 510(k) statement in the 

submission, § 807.93 requires that the 

official correspondent of the firm make 

available within 30 days of a request all 

information included in the submitted 

premarket notification on safety and 

effectiveness. This information will be 

provided to any person within 30 days 

of a request if the device described in 

the premarket notification submission is 

determined to be substantially 

equivalent. The information provided 

will be a duplicate of the premarket 

notification submission including any 

safety and effectiveness information, but 

excluding all patient identifiers and 

trade secret and confidential 

information. 

In the Federal Register of November 

3, 2006 (71 FR 64711), FDA published 

a 60-day notice requesting public 

comments on the proposed collection of 

information. In response to that notice, 

no comments were received. 

The most likely respondents to this 

information collection will primarily be 

medical device manufacturers including 

reprocessors of single-use devices, and 

initial importers of devices. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form 

Number 

Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

807 Subpart E 

(807.81, 

807.87, 

807.92, & 

807.93) 3,700 1 3,700 80 296,000 

807.87 3514 1,956 1 1,956 0.5 978 

807.90(a)(3) 3541 400 1 400 0.25 100 

807.87(d) and 

(f) 3654 150 1 150 1 150 

Totals 297,228 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

807.93 2,000 10 20,000 0.5 10,000 

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


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9007 

FDA has based these estimates on 

conversations with industry and trade 

association representatives, and from 

internal review of the documents listed 

in tables 1 and 2 of this document. 

Dated: February 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3444 Filed 2–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0193] 

Guidance for Industry: Eligibility 

Determination for Donors of Human 

Cells, Tissues, and Cellular and 

Tissue-Based Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Eligibility 

Determination for Donors of Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps),’’ dated 

February 2007. The guidance document 

assists establishments with making 

eligibility determinations for donors of 

human cells, tissues, and cellular and 

tissue-based products. The guidance 

announced in this document finalizes 

the draft guidance, ‘‘Guidance for 

Industry: Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps),’’ dated May 2004. This 

guidance also finalizes the draft 

guidance, ‘‘Guidance for Industry: 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps),’’

dated June 2002 (Docket No. 2002D–

0266). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1–

800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

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 to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps),’’ dated February 2007. The 

guidance announced in this document 

assists HCT/P establishments with 

complying with the requirements under 

part 1271 (21 CFR part 1271), subpart C. 

These regulations require HCT/P 

establishments to perform an eligibility 

determination for most cell and tissue 

donors, based on donor testing and 

screening for relevant communicable 

disease agents and diseases. This 

guidance applies only to cells and 

tissues procured on or after the effective 

date of the regulations contained in part 

1271, subpart C (effective date May 25, 

2005). This guidance does not replace 

the guidance on 21 CFR part 1270, 

‘‘Guidance for Industry: Screening and 

Testing of Donors of Human Tissue 

Intended for Transplantation,’’ dated 

July 29, 1997, which continues to apply 

to certain tissues recovered before May 

25, 2005. 

In the Federal Register of June 25, 

2002 (67 FR 42789), FDA announced the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps),’’

dated June 2002. The draft guidance 

provides information intended to assist 

manufacturers of HCT/Ps in minimizing 

the risk of transmission of CJD and vCJD 

by HCT/P donors that have been 

possibly exposed to the agents of CJD 

and vCJD. 

In the Federal Register of May 25, 

2004 (69 FR 29835), FDA announced the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Eligibility Determination for Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps),’’ dated 

Ma 2004. The draft guidance provided 

to HCT/P establishments 

recommendations for the appropriate 

screening and testing of cell and tissue 

donors for relevant communicable 

disease agents and diseases, and 

recommendations for complying with 

the regulations for eligibility 

determination for donors of HCT/Ps. 

FDA issued these two draft guidances 

to assist manufacturers in minimizing 

the risk of communicable disease 

transmission by donors of HCT/Ps. FDA 

received numerous comments on the 

two draft guidances and those 

comments were considered as the 

guidance was finalized. Based on these 

comments and additional data, FDA has 

identified West Nile Virus, Sepsis, and 

Vaccinia as relevant communicable 

disease agents or diseases (RCDAD). On 

the other hand, FDA has not included 

severe acute respiratory syndrome 

(SARS-CoV) as an RCDAD in this 

guidance because there has been no 

laboratory-confirmed person-to-person 

transmission of SARS-CoV worldwide 

since July 2003. In addition, the 

guidance recommends nucleic acid 

amplification testing (NAT) for human 

immunodeficiency virus (HIV) and 

hepatitis C virus (HCV) for both living 

and cadaveric donors. The guidance 

also modifies and/or clarifies the 

following: 

• Recommendations for risk factors 

for vCJD; 

• Physical examination of a living 

HCT/P donor; 

• Exceptions to the requirement for 

determining donor eligibility and 

appropriate labeling; 

• Screening criteria for HIV–1 group 

O, viral hepatitis, syphilis, Chlamydia 

trachomatis and Neisseria gonorrhea; 

• Deferral criteria for receipt of 

human-derived clotting factors; 

• Procedures for communicable 

disease testing laboratories; 

• FDA’s approach to identifying new 

RCDADs; and 

• Use of gestational carriers or 

surrogates. 

The guidance announced in this 

document finalizes the previously 

described draft guidances dated June 

2002 and May 2004. The guidance is 

being issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance represents FDA’s 

current thinking on this topic. 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 


sroberts on PROD1PC70 with NOTICES