82 Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Notices 

Its Subcommittee on Privacy and 

Confidentiality monitors developments in 

health information privacy and 

confidentiality on behalf of the full 

Committee and makes recommendations to 

the full Committee so that it can advise the 

Secretary on implementation of the health 

information privacy provisions of HIPAA. 

Purpose: This meeting of the 

Subcommittee on Privacy and Confidentiality 

will receive information on the 

implementation of the regulation ‘‘Standards 

for Privacy of Individually Identifiable 

Health Information’’ (45 CFR parts 160 and 

164), promulgated under the Health 

Insurance Portability and Accountability Act 

of 1996. 

The regulation and further information 

about it can be found on the Web site of the 

Office for Civil Rights, at http://

www.hhs.gov/ocr/hipaa/. The regulation has 

been in effect since April 14, 2001. Most 

entities covered by the regulation must come 

into compliance by April 14, 2003, and many 

are beginning the process of implementing it. 

The first day of the meeting will be 

conducted as a hearing, in which the 

Subcommittee will gather detailed 

information about implementation of the 

regulation’s provisions for use and disclosure 

of health information for marketing and 

fundraising. The Subcommittee will invite 

specific representatives of affected groups, in 

order to obtain information about practical 

issues in implementation of the regulation 

with respect to these uses and disclosures of 

information, and to obtain suggestions about 

possible solutions for such issues. 

The format will include one or more 

invited panels on these issues and time for 

questions and discussion. The Subcommittee 

will ask the invited witnesses for focused, 

detailed analyses and description, with 

examples, of the effect the regulation is 

expected to have, on individuals and on 

entities subject to the regulation, with respect 

to these matters, based on early 

implementation efforts and preliminary 

assessments of impact. 

The second day of the meeting will consist 

of Subcommittee discussion of the testimony 

it has heard and deliberations about possible 

recommendations to the Secretary.

In addition to the panels that will be 

invited to address these issues, members of 

the public who would like to make a brief (3 

minutes or less) oral comment on one or 

more of the specified issues during the 

hearing will be placed on the agenda as time 

permits. To be included on the agenda, 

please contact Marietta Squire (301) 458–

4524, by E-mail at mrawlinson@cdc.gov, or 

postal address at NCHS, Presidential 

Building, Room 1100, 6525 Belcrest Road, 

Hyattsville, Maryland 20782 by January 17, 

2002. 

Persons wishing to submit written 

testimony only (which should not exceed 

five double-spaced typewritten pages) should 

endeavor to submit it by that date. Unfilled 

slots for oral testimony will also be filled on 

the day of the meeting as time permits. Please 

consult Ms. Squire for further information 

about these arrangements. 

Additional information about the hearing 

will be provided on the NCVHS Web site at 

http://www.ncvhs.hhs.gov shorthy before the 

hearing date. 

Contact Person for More Information:

Information about the content of the hearing 

and matters to be considered may be 

obtained from John P. Fanning, Lead Staff 

Persons for the NCVHS Subcommittee on 

Privacy and Confidentiality, Office of the 

Assistant Secretary for Planning and 

Evaluation, U.S. Department of Health and 

Human Services, 440D Humphrey Building, 

200 Independence Avenue SW., Washington 

DC 20201, telephone (202) 690–5896, E-mail 

jfanning@osaspe.dhhs.gov. or from Marjorie 

S. Greenberg, Executive Secretary, NCVHS, 

NCHS, CDC, Room 1100, Presidential 

Building, 6525 Belcrest Road, Hyattsville, 

Maryland 20782, telephone (301) 458–4245. 

Information about the committee, including 

summaries of past meetings and a roster of 

committee members, is available on the 

Committee’s Web site at http://

www.ncvhs.hhs.gov.

Dated: December 20, 2001. 

James Scanlon, 

Director, Division of Data Policy, Office of 

the Assistant Secretary for, Planning and 

Evaluation.

[FR Doc. 01–32198 Filed 12–31–01; 8:45 am] 

BILLING CODE 4151–05–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Immunosuppressive Drugs 

Subcommittee of the Antiviral Drugs 

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public.

Name of Committee: 

Immunosuppressive Drugs 

Subcommittee of the Antiviral Drugs 

Advisory Committee.

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues.

Date and Time: The meeting will be 

held on January 24, 2002, from 8:30 a.m. 

to 5 p.m.

Location: Holiday Inn, The Ballrooms, 

Two Montgomery Village Ave., 

Gaithersburg, MD.

Contact: Tara P. Turner, Center for 

Drug Evaluation and Research (HFD–

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, e-mail: 

TurnerT@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 12531. 

Please call the Information Line for upto-date information on this meeting.

Agenda: The subcommittee will 

discuss new drug applications (NDAs) 

21–083/SE1–006 and 21–110/SE1–004, 

RAPAMUNE (sirolimus) oral solution 

and tablets, Wyeth-Ayerst Research, 

approved for prophylaxis of organ 

rejection in patients receiving renal 

transplants. As stated in the approved 

labeling, it is recommended that 

RAPAMUNE be used in a regimen with 

cyclosporine and corticosteroids. The 

discussion is for the proposed 

elimination of cyclosporine from the 

immunosuppressive regimen 2 to 4 

months after transplantation under 

certain conditions.

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by January 16, 2002. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before January 16, 2002, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: December 19, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–32175 Filed 12–31–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Blood Products Advisory Committee; 

Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of Food and Drug Administration (FDA). 

At least one portion of the meeting will 

be closed to the public.

Name of Committee: Blood Products 

Advisory Committee.