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 

Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 49931

activities and will issue a quarterly 

newsletter and develop a web page. 

4. To coordinate meetings for the 

Urban Indian health programs to 

provide training, technical assistance, 

and/or updated information addressing 

the health care needs of Urban Indians. 

Reporting Requirements:

1. Monthly Activity Report: The 

organization will provide to the IHS 

program office a monthly report 

detailing activities performed for the 

organization. These activity reports will 

include: 

• Trip reports for travel in connection 

to the organization 

• Information on meetings attended 

by NCUIH regarding Indian health care 

education activities, and any 

documentation provided by NCUIH at 

these meetings 

• Information relative to health status 

and health care needs of urban Indians 

in urban centers 

2. Program Progress Report: Program 

progress reports are required semiannually. These reports will include 

brief comparison of actual 

accomplishments to the goals 

established for the period, reasons for 

slippage (if applicable), and other 

pertinent information as required. A 

final report is to be submitted within 90 

days of expiration of the budget/project 

period. 

3. Financial Status Report: Financial 

status reports are required semiannually. Standard Form 269 (long 

form) will be used for financial 

reporting. A final report must be 

submitted within 90 days of expiration 

of the budget/project period. 

4. Financial Audit: A financial audit, 

conducted by an independent auditor 

will be completed annually for each 

year within the project period (three). 

Failure to submit required reports 

within the time allowed may result in 

suspension or termination of the active 

cooperative agreement, withholding of 

payments or converting to the 

reimbursement method of payment. 

Continued failure to submit required 

reports may result in the imposition of 

special award provisions, or cause other 

eligible projects or activities involving 

the grantee organization not to be 

funded. 

Justification for Single Source: This 

project has been awarded on a noncompetitive single source basis. NCUIH 

is the only nationwide Indian 

organization that is specifically 

established to address the health needs 

of American Indians and Alaska Natives 

living in urban areas with membership 

consisting of Urban Indian health 

organizations funded under Title V of 

the Indian Health Care Improvement 

Act, Public Law 93–437, as amended, 

and under authority 25 U.S.C. 1652. 

Furthermore, it is the only nationwide 

organization for urban American 

Indians and Alaska Natives supporting 

the growth of the Urban Indian health 

care delivery system. 

Use of Cooperative Agreement: A 

cooperative agreement has been 

awarded because of anticipated 

substantial Programmatic involvement 

by IHS staff in the project. Substantial 

programmatic involvement is as follows: 

1. IHS staff will participate in the 

Board of Director meetings. Purposes 

will be to present the IHS prospectus on 

current health care issues affecting the 

Urban Indian people and allow IHS the 

opportunity to hear the continuing 

unmet needs of Urban Indians. 

2. IHS staff may, at the request of 

NCUIH, participate on study groups and 

may recommend topics for 

consideration. 

3. IHS will be involved in the 

selection and approval process for 

hiring key personnel. Key personnel are 

the Executive Director, the Office 

Administrator, and may include the 

hiring of major consultants. NCUIH 

must submit the Executive Director and 

Office Administrator selection criteria to 

IHS for approval when there becomes a 

change in staffing.; 

4. IHS will be involved in meetings 

held by NCUIH. 

Contacts: For program information, 

contact Ms. Danielle Steward, Program 

Specialist, Office of Urban Indian 

Health Programs, Office of the Director, 

Indian Health Service, Reyes Building, 

801 Thompson Avenue, Rockville, MD, 

20852, (301) 443–4680. For grants 

management information, contact Lois 

Hodge, Grants Management Officer, 

Division of Grants Operations, Reyes 

Building, 801 Thompson Avenue, 

Rockville, MD, 20852, (301) 443–5204.

Dated: August 19, 2005. 

Mary Lou Stanton, 

Deputy Director for Indian Health Policy 

Indian Health Service.

[FR Doc. 05–16912 Filed 8–24–05; 8:45 am] 

BILLING CODE 4156–16–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Privacy Act of 1974; Report of Modified 

or Altered System

AGENCY: Indian Health Service (IHS), 

HHS.

ACTION: Notice of proposed modification 

or Alteration to a System of Records 

(SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

we are proposing to modify or alter an 

SOR, ‘‘Health, Medical and Billing 

Records (formerly known as the Health 

and Medical Records Systems),’’ System 

No. 09–17–0001. We propose to include 

contract health service records, as an 

additional category of individuals 

covered by the system, which consists 

of medical records to eligible American 

Indians and Alaska Native (AI/AN) 

people that supplements the health care 

resources available with the purchase of 

medical care and services that are not 

available within the IHS direct care 

system which may include, but not 

limited to, basic and specialty health 

care services from local and community 

health care providers, including 

hospital care, physician services, 

outpatient care, laboratory, dental, 

radiology, pharmacy, and transportation 

services. Under the Purpose of the 

system, we propose to include several 

new purposes that are in line with the 

Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule provisions which were 

incorporated into the published IHS 

Notice of Privacy Practices (NPP) and to 

include debt collection activities. We 

are proposing to modify/alter/delete 

several published routine uses, as 

explained, to accommodate for program 

and statutory changes as indicated: 

Number 1 is modified/altered by 

separating the medical treatment, 

payment and health care operations into 

two separate routine uses 1 and 2 to 

include payment, billing, third-party 

reimbursement and debt collection 

activities; numbers 3, 4 and 11 are to 

include business associate agreement 

language to comply with HIPAA Privacy 

standards and renumbered as 5, 6 and 

12 respectively; number 5 is to include 

a special requirement notice for 

sensitive protected health information 

(PHI) such as alcohol/drug abuse, HIV/

AIDS, STD or mental health patient 

information and renumbered as 7; 

number 6 is to reflect changes in 

research disclosures to comply with 

HIPAA Privacy standards and 

renumbered as 8; number 7 is to include 

various cases of abuses, neglect, sexual 

assault and domestic violence and 

emphasis on meeting the requirements 

of 42 CFR part 2 and renumbered as 9; 

number 8 is to clarify the disclosures 

regarding suspected cases of child abuse 

and renumbered as 10; number 9 is 

modified to include legal proceedings 

related to administrative claims and the 

inclusive provision of the Department of 

Health and Human Services (DHHS)/

Office of General Counsel (OGC)