Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Notices 70915

Stephen C. Groft, Pharm.D., Executive

Director, 6701 Rockledge Drive, Room

1010, MSC 7707, Bethesda, MD 20817–

7707, Phone: (301) 435–7592, Fax: (301)

480–1691, E-mail:

WHCCAMP@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The

President established the White House

Commission on Complementary and

Alternative Medicine Policy on March

7, 2000, by Executive Order 13147. The

mission of the White House

Commission on Complementary and

Alternative Medicine Policy is to

provide a report, through the Secretary

of the Department of Health and Human

Services, on legislative and

administrative recommendations for

assuring that public policy maximizes

the benefits of complementary and

alternative medicine to Americans.

Public Participation

Oral statements by the public will be

provided on December 4, from about

1:30 p.m.–2:30 p.m. (Time

approximate). Members of the public

who wish to present oral comment may

register by calling 1–800–953–3298 or

by accessing https://safe2.sba.com/

whccamp/index.cfm or the website of

the Commission at http://

whccamp.hhs.gov no later than

November 27, 2000.

Oral comments will be limited to five

minutes; three minutes of oral

presentation and two minutes to

respond to questions by Commission

members. Individuals who register to

speak will be assigned in the order in

which they registered. Due to time

constraints, only one representative

from each organization will be allotted

time for oral testimony. The number of

speakers and the time allotted may also

be limited by the number of registrants.

All requests to register should include

the name, address, telephone number,

and business or professional affiliation

of the interested party, and should

indicate the area of interest or question

(as described above) to be addressed.

When mailing or faxing written

comments provide, if possible, an

electronic version on diskette.

Any person attending the meeting

who has not registered to speak in

advance of the meeting will be allowed

to make a brief oral statement during the

time set aside for public comment if

time permits, and at the chairperson’s

discretion. Individuals unable to attend

the meeting, or any interested parties,

may send written comments by mail,

fax, or electronically to the staff office

of the Commission for inclusion in the

public record.

Because of the need to obtain the

views of the public on these issues as

soon as possible and because of the

early deadline for the report required of

the Commission, this notice is being

provided at the earliest possible time.

Dated: November 17, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–30175 Filed 11–27–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the Office of Research Integrity (ORI)

and the Assistant Secretary for Health

have taken final action in the following

case:

Evan B. Dreyer, M.D., Ph.D.,

Massachusetts Eye and Ear Infirmary

(MEEI) and Harvard Medical School

(HMS): Based on the findings and

evidence documented in a report by a

joint inquiry panel, dated November 17,

1997, and additional information

obtained by the Office of Research

Integrity (ORI) during its oversight

review, on April 14, 2000, PHS issued

its findings that Dr. Dreyer, former HMS

Associate Professor of Ophthalmology at

MEEI, engaged in scientific misconduct

by falsifying or fabricating experimental

results. These results were included in

National Institute on Deafness and

Other Communication Disorders

(NIDCD), National Institutes of Health

(NIH), grant application K08 DC00131–

01A1.

Specifically, Dr. Dreyer falsified or

fabricated experimental results to

support the hypothesis that elevated

levels of the amino acid glutamate play

a role in Meniere’s disease and reported

these falsified or fabricated results in six

documents:

1. An NIH grant application, K08

DC0013 l–0lA1, ‘‘Glutamate toxicity in

endolymphatic hydrops,’’ submitted to

NIH for a Mentored Clinical Scientist

Development Award in July 1996. PHS

found that the experimental results for

19 amino acids reported in Table 2 and

the text (pp. 58–59) were falsified or

fabricated.

2. An abstract, Cliff A. Megerian,

M.D., Michael J. McKenna, M.D., Joseph

B. Nadol, Jr., M.D., and Evan B. Dreyer,

M.D., Ph.D. ‘‘Elevated Perilymphatic

Glutamate and Type-1 Spiral Ganglion

Cell Loss in the Hydropic Ear,’’

submitted on August 1, 1996, for the

Triological Society Eastern Division

Meeting scheduled for early February

1997. PHS found that the text reports

the same falsified or fabricated

experimental results for the amino acid

glutamate that were reported in the K08

DC00131–OlA1 grant application to

support the conclusion that elevated

levels of glutamate may play a role in

Meniere’s disease.

3. A manuscript, Cliff A. Megerian,

M.D., Michael J. McKenna, M.D., Joseph

B. Nadol, Jr., M.D., Barbara J. Burgess,

B.A., David Zurakowski, Ph.D., and

Evan B. Dreyer, M..D., Ph.D. ‘‘Elevated

Perilymphatic Glutamate and Type-1

Spiral Ganglion Cell Loss in the

Hydropic Ear.’’ PHS found that Table 1

and the text (pp. 2 and 8) contained the

same falsified or fabricated

experimental results that were reported

in the K08 DC00131–OlA1 grant

application.

4. A draft NIH grant application,

listing Dr. Dreyer as Principal

Investigator, in which Table 2 and the

text of the draft NIH grant application

contained the same experimental results

that the PHS found were falsified or

fabricated in K08 DC00131-OlA1.

5. Two computer spreadsheets, which

contained the same results that the PHS

found were falsified or fabricated in the

K08 DC00131-OlA1.

6. Magneto-optical computer disk,

which contained files with 21 fabricated

chromatograms of amino acid elution

patterns. On January 21, 1997, Dr.

Dreyer provided the computer disk to

MEEI officials in response to requests

for the primary data and laboratory

notebooks supporting the amino acid

results reported in the documents

described above. On April 7 and May

21, 1997, Dr. Dreyer admitted that he

fabricated each of the 21

chromatograms.

On May 10, 2000, Dr. Dreyer appealed

the proposed PHS findings and

administrative actions to the HHS

Departmental Appeals Board (‘‘DAB’’),

DAB Docket No. A–2000–72. However,

on November 13, 2000, Dr. Dreyer

entered into a Voluntary Exclusion

Agreement (Agreement) with PHS in

which he agreed to withdraw his appeal

of the PHS findings of scientific

misconduct against him.

Under the terms of the Agreement,

with respect to the items in Paragraphs

1–5, Dr. Dreyer did not admit that he

falsified or fabricated the results at

issue, but he recognized that if the DAB

case proceeded to conclusion, there was

sufficient evidence upon which the

DAB may make a finding of scientific

70916 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Notices

misconduct. With respect to the

material identified in Paragraph 6, Dr.

Dreyer admitted that he fabricated the

21 chromatograms contained in the

magneto-optical computer disk that he

provided to institutional officials after

questions were raised about his

research. Dr. Dreyer further admitted

that the fabrication of the data on the

disk amounts to scientific misconduct.

Dr. Dreyer has voluntarily agreed for

a period of ten (10) years, beginning on

November 15, 2000, to exclude himself

from:

(1) Any contracting or subcontracting

with any agency of the United States

Government and from eligibility for, of

involvement in, nonprocurement

transactions (e.g., grants and cooperative

agreements of the United States

Government as defined in 45 CFR Part

76 (Debarment Regulations);

(2) Serving as a mentor to any

graduate student, fellow, or other

individual who applies for or receives

Federal funding; and

(3) Serving in any capacity to PHS,

including but not limited to service on

any PHS advisory committee, board,

and/or peer review committee, or as a

consultant.

The above voluntary exclusion,

however, does not apply to Dr. Dreyer’s

practice of clinical medicine as a

licensed practitioner or to Federal funds

used for purposes of teaching or training

medical students, residents, or fellows,

in clinical medical matters.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative

Oversight, Office of Research Integrity,

5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris Pascal,

Director, Office of Research Integrity.

[FR Doc. 00–30236 Filed 11–27–00; 8:45 am]

BILLING CODE 4150–31–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Statement of Organization, Functions,

and Delegations of Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organizations, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 65 FR 68144, dated

November 14, 2000) is amended to

revise the functional statement of the

Division for AIDS, STD, and TB

Laboratory Research (DASTLR),

National Center of Infections (NCID).

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete the functional statement for the

Division of AIDS, STD and TB

Laboratory Research (HCRN) and insert

the following:

Division of AIDS, STD and TB

Laboratory Research (HCRN). (1)

Develops and evaluates laboratory

methods and procedures for the

diagnosis and characterization of

infections caused by human

immunodeficiency virus (HIV) and

other retroviruses, other sexually

transmitted diseases (STDs), and

mycobacteria including Mycobacterium

tuberculosis; (2) provides laboratory

support for the surveillance,

epidemiologic, and clinical activities of

the National Center for HIV, STD, and

TB Prevention (NCHSTP); (3) conducts

applied research on the pathogenesis of

and the immune mechanisms that occur

in microbial infections; (4) conducts

laboratory studies of hemophilia and

other coagulating disorders; (5) provides

reference laboratory services and assists

in standardizing and providing

laboratory reagents; (6) serves as a

World Health Organization

Collaborating Center; (7) conducts

epidemiologic studies of HIV-infected

and uninfected persons with

hemophilia and their families; (8) assists

in designing, implementing, and

evaluating prevention and counseling

programs for HIV-infected persons with

hemophilia and their families; and (9)

coordinates research on opportunistic

infections occurring in HIV-infected

persons.

Dated: November 15, 2000.

Jeffrey P. Koplan,

Director.

[FR Doc. 00–30217 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1599]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Use of ImpactResistant Lenses in Eyeglasses and

Sunglasses

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

recordkeeping requirements to insure

public health and safety for

manufacturers of impact-resistant lenses

used in eyeglasses and sunglasses.

DATES: Submit written or electronic

comments on the collection of

information by January 29, 2001.

ADDRESSES: Submit written or electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary