76642 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Notices

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before January 8, 2001.

If you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Les

Smith, Federal Communications

Commission, Room 1–A804, 445 12th

Street, SW., Washington, DC 20554 or

via the Internet to lesmith@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Les

Smith at (202) 418–0217 or via the

Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060–0684.

Title: Amendment to the

Commission’s Rules Regarding a Plan

for Sharing Costs of Microwave

Relocation, WT Docket No. 95–157, FCC

No. 00–123

Form Number: N/A.

Type of Review: Revision of a

currently approved collection.

Respondents: Business or other forprofit entities; Individuals or

households.

Number of Respondents: 2,000.

Estimate Time Per Response: 54 mins.

(avg.).

Frequency of Response: Biennial and

on occasion reporting requirements;

Third party disclosure.

Total Annual Burden: 1,790 hours.

Total Annual Costs: $862,000.

Needs and Uses: On April 5, 2000, the

FCC adopted an Order on

Reconsideration which revised its rules

to effectuate the relocation of fixed

microwave incumbents from the 2 GHz

band to clear spectrum for the

development of PCS. In doing so, the

FCC implemented its plan for PCS

relocators and subsequent PCS licensees

to share the costs of relocating existing

2 GHz microwave facilities, thus

providing for a fair and efficient

relocation process. These rules, which

govern both the relocation and costsharing plans, foster the development of

competitive broadband PCS service

throughout the country, while

permitting incumbent providers of

microwave service to relocate to higher

spectrum bands. This information

collection facilitates dispute resolution

for PCS relocators and microwave

licensees independent of the

Commission and assists PCS relocators

and microwave licensees when they

negotiate relocation agreements.

Furthermore, the information collection

helps two industry clearinghouses

maintain a national database, determine

reimbursement obligations of

subsequent PCS entities under the

Commission’s cost-sharing rules, and

notify subsequent PCS entities of their

obligations.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–31171 Filed 12–6–00; 8:45 am]

BILLING CODE 6712–01–U

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Submitted to OMB

for Review and Approval

December 1, 2000.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection, as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before January 8, 2001.

If you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Les

Smith, Federal Communications

Commission, Room 1–A804, 445 12th

Street, S.W., Washington, DC 20554 or

via the Internet to lesmith@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Les

Smith at (202) 418–0217 or via the

Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060–0192.

Title: Section 87.103, Posting Station

License.

Form Number: N/A.

Type of Review: Extension of a

currently approved collection.

Respondents: Recordkeeping.

Number of Respondents: 47,800.

Estimate Time Per Response: 15 mins.

Frequency of Response:

Recordkeeping.

Total Annual Burden: 11,950 hours.

Total Annual Costs: None.

Needs and Uses: The recordkeeping

requirement in 47 CFR Section 87.103 is

necessary to demonstrate that all

transmitters in the Aviation Service are

properly licensed in accordance with

the requirements of Section 301 of the

Communications Act of 1934, as

amended, 47 U.S.C. 301, No. 2020 of the

International Radio Regulations, and

Article 30 of the Convention on

International Civil Aviation. This

requirement facilitates the quick

resolution of any harmful interference

problems and ensures that the station is

operating in accordance with the

appropriate rules, statutes, and treaties.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–31228 Filed 12–6–00; 8:45 am]

BILLING CODE 6712–01–U

FEDERAL COMMUNICATIONS

COMMISSION

[Report No. 2452]

Petitions for Reconsideration of Action

in Rulemaking Proceeding

November 29, 2000.

Petitions for Reconsideration have

been filed in the Commission’s

rulemaking proceeding listed in this

Public Notice and published pursuant to

47 CFR Section 1.429(e). The full text of

this document is available for viewing

and copying in Room CY–A257, 445

12th Street, SW., Washington, DC or

may be purchased from the

Commission’s copy contractor, ITS, Inc.

(202) 857–3800. Oppositions to these

petitions must be filed by December 22,

2000. See Section 1.4(b)(1) of the

Commission’s rules (47 CFR 1.4(b)(1)).

Replies to an opposition must be filed

within 10 days after the time for filing

oppositions have expired.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Notices 76643

Subject: Amendment of 73.202(b)

Table of Allotments FM Broadcast

Stations (Windthorst, Texas).

Number of Petitions Filed: 2.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–31174 Filed 12–6–00; 8:45 am]

BILLING CODE 6712–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Secretary’s Advisory Committee on

Genetic Testing

AGENCY: Office of the Secretary, DHHS.

ACTION: Request for public comment on

a proposed classification methodology

for determining level of review for

genetic tests.

SUMMARY: The Secretary’s Advisory

Committee on Genetic Testing (SACGT)

was chartered to advise the Department

of Health and Human Services on the

medical, scientific, ethical, legal, and

social issues raised by the development

and use of genetic tests. SACGT recently

completed its first report, Enhancing the

Oversight of Genetic Tests (available at

http://www4.od.nih.gov/oba/

sacgt.html). One of SACGT’s major

recommendations was that all new

genetic tests be reviewed by the Food

and Drug Administration (FDA) before

they are used for clinical care or public

health purposes through ‘‘new and

innovative oversight mechanisms that

will not limit the development of new

tests or inordinately delay their

availability.’’ SACGT also recommended

that FDA correlate the level of review

applied to each genetic test with the

level of scrutiny warranted by the test.

To assist FDA in determining which

tests warrant greater scrutiny, SACGT is

developing a classification

methodology. A SACGT Working Group

on Genetic Test Classification,

composed of SACGT members and ad

hoc experts, met on August 3, 2000, to

identify criteria for assessing the risks

and benefits of genetic tests that could

serve as the basis for a classification

scheme. The full Committee endorsed

the working group’s approach on

August 4, 2000. Due to further analysis

of the proposed approach and concerns

raised by professional genetics and

laboratory organizations about its

practicality, SACGT revisited the initial

proposal at its November 2–3 meeting.

SACGT modified the methodology and

agreed that additional input from public

and professional organizations should

be gathered. It is now seeking public

comments on the rationale and

feasibility of the proposed test

classification methodology and several

specific questions.

DATES: The public is encouraged to

submit written comments on the

proposed classification methodology by

January 25, 2001 in order for SACGT to

consider the comments at its next

meeting in February 2001. The

following mailing address should be

used: SACGT, National Institutes of

Health, 9000 Rockville Pike, Building 1,

Room 103, Bethesda, Maryland, 20892.

SACGT’s facsimile number is 301–496–

9839. Comments can also be sent via email to hagas@od.nih.gov. All public

comments received will be available for

public inspection at the SACGT office

between the hours of 8:30 a.m. and 5

p.m.

FOR FURTHER INFORMATION CONTACT:

Questions about this request for public

comment can be directed to Dr. Susanne

Haga, by e-mail (hagas@od.nih.gov) or

telephone (301–496–9838). The

methodology will also be posted on

SACGT’s website for review and

comment.

SUPPLEMENTARY INFORMATION:

Background

Decades of genetics research have

brought about many important medical

and public health advances. The pace of

discovery in this area has enabled

scientists to make rapid progress in

understanding the role of genetics in

many common yet complex diseases

and conditions, such as heart disease,

cancer, and diabetes. It also has

increased knowledge that may lead to

the development of new tests to identify

these disease conditions in individuals,

sometimes before symptoms occur.

According to GeneTests, a genetic

testing laboratory directory, genetic

testing is clinically available for more

than 400 diseases or conditions in more

than 200 laboratories in the United

States, and investigators are exploring

the development of tests for an

additional 338 diseases or conditions.

However, most of the current genetic

testing is for single gene disorders such

as Huntington disease and cystic

fibrosis.

Genetic tests can be performed for a

number of purposes. Moreover, a test

can be used in more than one way, such

as when a test used for diagnostic

purposes is also used to predict risk of

disease. SACGT included the following

types of testing within its definition: (1)

an analysis performed on human DNA,

RNA, genes, and/or chromosomes to

detect heritable or acquired genotypes,

mutations, phenotypes, or karyotypes

that cause or are likely to cause a

specific disease or condition; and (2) the

analysis of human proteins and certain

metabolites, which are predominantly

used to detect heritable or acquired

genotypes, mutations, or phenotypes.

The purposes of both these types of

genetic tests include predicting risks of

disease, screening of newborns,

directing clinical management,

identifying carriers, and establishing

prenatal or clinical diagnoses or

prognoses in individuals, families, or

populations. Not included in this

definition are tests that are used

primarily for other purposes, but that

may contribute to diagnosing a genetic

disease (e.g., blood smear, certain serum

chemistries), and tests conducted

exclusively for forensic identification

purposes.

In the past, many tests were

developed to detect or confirm rare

genetic diseases. More recently, tests

have been developed to detect

mutations that may be involved in or

contribute to more common, complex

conditions (such as breast, ovarian, and

colon cancer and cardiovascular

disease), the effects of which generally

do not appear until later in life.

Optimally, these tests are used to

predict a person’s predisposition to

disease where there is a family history

of the disease, and in general, such tests

are not recommended for individuals

without such a history. However, in the

future, the use of predictive tests may

expand and be offered to individuals

without a family history of certain

diseases and conditions, e.g., common

adult-onset disorders.

In Enhancing the Oversight of Genetic

Tests, SACGT recommended that all

new genetic tests be reviewed by the

Food and Drug Administration (FDA)

before they are used for clinical care or

public health purposes. The Committee

suggested that FDA’s review be

accomplished through ‘‘new and

innovative oversight mechanisms that

will not limit the development of new

tests or inordinately delay their

availability.’’ Determining the level of

review required of a particular genetic

test is crucial to ensuring that a test

receives the appropriate level of review

based on the characteristics of the test

and its target disease or condition. In

order to determine the appropriate level

of review for genetic tests, SACGT

concluded that a classification

methodology was needed.

To assist FDA in determining the

appropriate level of review, a working

group on genetic test classification was

convened in August, composed of

SACGT members and ad hoc experts.

The goal of the working group was to