Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 49929

that the total reporting costs of sponsors 

would be less than $450,000 annually. 

Costs could also occur after a marketing 

application is submitted if FDA 

determines that the financial interests of 

an investigator raise significant 

questions about the integrity of the data.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section 

No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses Hours Per Response Total Hours 

54.4(a)(1) and (a)(2) 1,000 1 1,000 5 5,000

54.4(a)(3) 100 1 100 20 2,000

54.4 46,000 .25 11,500 .1 11,500

Total 18,500

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

The sponsors of covered studies will 

be required to maintain complete 

records of compensation agreements 

with any compensation paid to 

nonemployee clinical investigators, 

including information showing any 

financial interests held by the clinical 

investigator, for a time period of 2 years 

after the date of approval of the 

applications. This time is consistent 

with the current recordkeeping 

requirements for other information 

related to marketing applications for 

human drugs, biologics, and medical 

devices. Currently, sponsors of covered 

studies must maintain many records 

with regard to clinical investigators, 

including protocol agreements and 

investigator resumes or curriculum 

vitae. FDA estimates than an average of 

15 minutes will be required for each 

recordkeeper to add this record to 

clinical investigators’ file.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency per

Recordkeeping Total Annual Records 

Hours Per

Recordkeeper Total Hours 

54.6 1,000 1 1,000 .25 250

Total 250

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

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16915 Filed 8–24–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D–0264]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Ribonucleic Acid Preanalytical 

Systems (Ribonucleic Acid Collection, 

Stabilization and Purification Systems 

for Real Time Polymerase Chain 

Reaction Used in Molecular Diagnostic 

Testing); Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: RNA Preanalytical Systems 

(RNA Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing).’’ This 

guidance document describes a means 

by which Ribonucleic Acid (RNA) 

preanalytical systems may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule to classify RNA 

preanalytical systems into class II 

(special controls). This guidance 

document is immediately in effect as the 

special control for RNA preanalytical 

systems but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

RNA Preanalytical Systems (RNA 

Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing)’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance.

Submit written comments concerning 

this 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT: Uwe 

Scherf, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying RNA preanalytical systems 

into class II (special controls) under 

49930 Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 

section 513(f)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360c(f)(2)). This guidance 

document will serve as the special 

control for RNA preanalytical systems.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act (21 U.S.C. 360(k)) for 

a device that has not previously been 

classified may, within 30 days after 

receiving an order classifying the device 

in class III under section 513(f)(1) of the 

act, request FDA to classify the device 

under the criteria set forth in section 

513(a)(1) of the act. FDA shall, within 

60 days of receiving such a request, 

classify the device by written order. 

This classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s GGP regulation 

(21 CFR 10.115). The guidance 

represents the agency’s current thinking 

on RNA preanalytical systems. 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

To receive ‘‘Class II Special Controls 

Guidance Document: RNA Preanalytical 

Systems (RNA Collection, Stabilization 

and Purification Systems for RT–PCR 

used in Molecular Diagnostic Testing)’’ 

by fax call the Center for Devices and 

Radiological Health (CDRH) Facts-OnDemand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt, press 1 to 

order a document. Enter the document 

number (1563) followed by the pound 

sign (#). Follow the remaining voice 

prompts to complete your request.

To receive ‘‘Class II Special Controls 

Guidance Document: RNA Preanalytical 

Systems (RNA Collection, Stabilization 

and Purification Systems for RT–PCR 

used in Molecular Diagnostic Testing),’’ 

you may either send a fax request to 

301–443–8818 to receive a hard copy of 

the document, or send an e-mail request 

to gwa@cdrh.fda.gov to receive a hard 

copy or an electronic copy. Please use 

the document number (1563) to identify 

the guidance you are requesting.

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. 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 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/

ohrms/dockets.

IV. Paperwork Reduction Act of 1995

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485.

V. Comments

Interested persons may submit written 

or electronic comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES). 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 9, 2005.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 05–16913 Filed 8–24–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Research and Demonstration Projects 

for Indian Health

AGENCY: Indian Health Service, HHS.

ACTION: Notice of single source 

cooperative agreement with the National 

Council of Urban Indian Health. 

SUMMARY: The Indian Health Service 

(IHS) announces the award of a 

cooperative agreement to the National 

Council of Urban Indian Health 

(NCUIH) for demonstration project for 

urban Indian health care education, 

consultation, health care data 

dissemination, training, and technical 

assistance to determine the unmet 

health care needs of urban Indians and 

to assist the Secretary in assessing the 

health status and health care of urban 

Indians. The project is for a three year 

project period effective September 1, 

2005 to August 31, 2008. Annual 

funding for the project is $417,000. 

The award is issued under the 

authority of the Public Health Service 

Act, Section 301 and the Indian Health 

Care Improvement Act, Public Law 94–

437, Sections 503, 504, and 511, and is 

listed under Catalog of Federal Domestic 

Assistance number 93–933. 

The specific objectives of the project 

are: 

1. NCUIH will keep the Urban Indian 

health programs and the IHS informed 

of items of interest pertaining to the 

health status and unmet needs of urban 

Indians and the federal budget process 

by reviewing activities that have taken 

place in regard to Indian health care. 

2. To disseminate information relative 

to Title V, local Urban Indian health 

issues, training opportunities, research 

instruments, data, budget, NCUIH 

activities and various forms of technical 

assistance to the Urban Indian health 

programs, keeping IHS informed of 

activities taking place. 

3. To disseminate information and 

respond to all inquiries relative to Title 

V, local Urban Indian health issues, 

training opportunities, research 

instruments, data, budget, NCUIH