56196 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Recombinant DNA Research: Actions

Under the Guidelines

AGENCY: National Institutes of Health

(NIH), PHS, DHHS.

ACTION: Notice of Actions under the NIH

Guidelines for Research Involving

Recombinant DNA Molecules (NIH

Guidelines).

SUMMARY: This notice sets forth actions

to be taken by the Director, National

Institutes of Health (NIH), under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules (59 FR

34496, amended 59 FR 40170, 60 FR

20726, 61 FR 1482, 61 FR 10004, 62 FR

4782).

FOR FURTHER INFORMATION CONTACT:

Background documentation and

additional information can be obtained

from the Office of Recombinant DNA

Activities (ORDA), National Institutes of

Health, MSC 7010, 6000 Executive

Boulevard, Suite 302, Bethesda,

Maryland 20892–7010, Phone 301–496–

9838, FAX 301–496–9839. The ORDA

web site is located at http://

www.nih.gov/od/orda/ for further

information about the office.

SUPPLEMENTARY INFORMATION: Today’s

actions are being promulgated under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules (NIH

Guidelines). The proposed actions were

published for comment in the Federal

Register of August 20, 1997 (62 FR

44387), and reviewed by the NIH

Recombinant DNA Advisory Committee

(RAC) at its meeting on September 12,

1997.

I. Background Information and

Decisions on Actions Under the NIH

Guidelines

Amendment to the Submission

Requirements—Human Gene Transfer

Experiments Under Appendix M of the

NIH Guidelines

During the June 12–13, 1997, RAC

meeting, the following motions were

approved by the RAC: (1) A motion was

made to eliminate the point-by-point

responses to Appendix M–II through M–

V, Description of the Proposal, Informed

Consent, Privacy and Confidentiality,

and Special Issues; however, the

questions raised in Appendix M–II

through M–V must be addressed in the

clinical protocol. The motion passed by

a vote of 8 in favor, 0 opposed, and 1

abstention. (2) A motion was made to

amend the Appendix M–I, Submission

Requirements—Human Gene Transfer

Proposals of the NIH Guidelines with

regard to: (i) The clinical protocol

(including discussion of issues in

Appendix M–II through M–V), and (ii)

deletion of the requirement of three 31⁄2

inch diskettes with the complete vector

nucleotide sequence in ASCII format.

The motion passed by a vote of 7 in

favor, 0 opposed, and 1 abstention.

The RAC recommendations were

published as proposed actions in the

Federal Register of August 20, 1997, for

public comment. A letter dated

September 8, 1997, was received in

response to the Federal Register notice

from Alexander E. Kuta, Ph.D., Director,

Regulatory Affairs, Genzyme

Corporation, Framingham,

Massachusetts. Genzyme disagreed with

the motion to incorporate the responses

to Appendix M–II through M–V into the

clinical protocol stating that ‘‘this action

would compromise the integrity of the

clinical protocol without sufficiently

addressing industry’s concerns

regarding Appendix M. * * * The

clinical protocol * * * should be

‘directed primarily at providing an

outline of the investigation.’ ’’At the

September 12, 1997, RAC meeting, the

RAC considered the comment from

Genzyme and agreed to give the

investigators or the sponsors the option

to provide the discussion of all

pertinent issues raised in Appendix M–

II through M–V either in the clinical

protocol or as an appendix to the

clinical protocol.

A motion was made to eliminate the

point-by-point responses to Appendix

M–II through M–V, and discussion of all

pertinent issues raised in Appendix M–

II through M–V must be provided either

in the clinical protocol or as an

appendix to the clinical protocol. The

motion passed by a vote of 10 in favor,

2 opposed, and 0 abstention.

No comments were received from the

public in response to the proposed

actions in the Federal Register of

August 20, 1997, with regard to the RAC

recommendation to delete the

requirement of three 31⁄2 inch diskettes

with the complete vector nucleotide

sequence in ASCII format from

Appendix M–I, Submission

Requirements—Human Gene Transfer

Proposals of the NIH Guidelines.

The actions are detailed in Section

II—Summary of Actions. I accept the

RAC recommendations, and the NIH

Guidelines will be amended

accordingly.

II. Summary of Actions

Appendix M–I, Submission

Requirements—Human Gene Transfer

Proposals of the NIH Guidelines, is

amended to read:

‘‘Appendix M–I. Submission

Requirements—Human Gene Transfer

Proposals

Investigators must submit the

following material to the Office of

Recombinant DNA Activities, National

Institutes of Health/MSC 7010, 6000

Executive Boulevard, Suite 302,

Bethesda, Maryland 20892–7010, (301)

496–9838 (see exemption in Appendix

M–IX–A, Footnotes of Appendix M).

Proposals will be submitted in the

following order: (1) Scientific abstract—

1 page; (2) non-technical abstract—1

page; (3) Institutional Biosafety

Committee (IBC) and Institutional

Review Board (IRB) approvals and their

deliberations pertaining to your protocol

(the IBC and IRB may, at their

discretion, condition their approval on

further specific deliberation by the

RAC); (4) Responses to Appendix M–II

through M–V, Description of the

Proposal, Informed Consent, Privacy

and Confidentiality, and Special Issues

(the pertinent responses can be

provided in the protocol or as an

appendix to the protocol); (5) protocol

(as approved by the local IBC and

IRB)—20 pages; (6) Informed Consent

document—approved by IRB (see

Appendix M–III, Informed Consent); (7)

appendices (including tables, figures,

and manuscripts); and (8) curricula

vitae—2 pages for each key professional

person in biographical sketch format.’’

OMB’s ‘‘Mandatory Information

Requirements for Federal Assistance

Program Announcements’’ (45 FR

39592) requires a statement concerning

the official government programs

contained in the Catalog of Federal

Domestic Assistance. Normally NIH lists

in its announcements the number and

title of affected individual programs for

the guidance of the public. Because the

guidance in this notice covers virtually

every NIH and Federal research program

in which DNA recombinant molecule

techniques could be used, it has been

determined not to be cost effective or in

the public interest to attempt to list

these programs. Such a list would likely

require several additional pages. In

addition, NIH could not be certain that

every Federal program would be

included as many Federal agencies, as

well as private organizations, both

national and international, have elected

to follow the NIH Guidelines. In lieu of

the individual program listing, NIH

invites readers to direct questions to the

information address above about

whether individual programs listed in

the Catalog of Federal Domestic

Assistance are affected.
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices 56197

Effective Date: October 20, 1997.

Harold Varmus,

Director, National Institutes of Health.

[FR Doc. 97–28624 Filed 10–28–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

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

Organization, 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 62 FR 51474 and 51479,

dated October 1, 1997) is amended to

reflect organizational changes within

the National Center for Infectious

Diseases (NCID), Centers for Disease

Control and Prevention.

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete the functional statement for the

Scientific Resources Program (CRL) and

insert the following:

(1) Provides animals, animal blood

products, glassware, mammalian tissue

cultures, microbiological media, special

reagents, and other laboratory materials

in support of research and service

activities to NCID laboratories and other

CDC organizations; (2) installs,

fabricates, modifies, services, and

maintains laboratory equipment used in

the research and service activities of

CDC; (3) develops and implements

applied research programs to expand

and enhance the use of animal models

necessary to support research and

diagnostic programs and to improve

breeding and husbandry procedures; (4)

conducts both basic and applied

research in cell biology and in the

expansion of tissue culture technology

as a research and diagnostic tool for

infectious disease activities; (5) provides

services for NCID investigators in

protein and DNA synthesis and

sequencing; (6) maintains a bank of

serum specimens of epidemiological

and special significance to CDC’s

research and diagnostic activities; (7)

obtains and distributes experimental

vaccines and drugs, antisera and

antitoxins, and immune globulins; (8)

for reagents prepared at CDC, maintains

a computerized inventory; provides

dispensing, lyophilization, capping, and

labeling; and retrieves from storage and

ships to requesters; (9) provides support

for liquid nitrogen freezers; (10)

maintains an international

hemoglobinometry reference laboratory;

(11) produces, maintains, and

distributes national and international

hemoglobin reference standard

preparations; (12) administratively and

technically supports the CDC Animal

Policy Board and the Atlanta Area

Animal Care and Use Committee; (13)

provides computer support services for

the Program’s activities.

Delete the title and functional

statement for the Molecular Pathology

and Ultrastructure Activity (CRUE) and

insert the following:

Infectious Disease Pathology Activity

(CRUE)

(1) Serves as a scientific and technical

resource to NCID by providing expertise

in molecular pathology, histopathology,

and ultrastructural analysis for detecting

infectious disease agents and studying

the interactions between microbial

agents and host cells; (2) develops,

improves, evaluates, and applies special

ultrastructural, immunohistologic, and/

or nucleic acid probe technologies for

detecting microbial agents and/or

expressed gene products in tissue

specimens or tissue culture; (3)

conducts basic and applied research

into the pathogenesis of infectious

diseases; (4) provides intramural and

extramural technical and professional

expertise for assistance in training in

infectious disease pathology and

molecular approaches to the

identification of specific nucleic acid

sequences and specific antigens in

tissue specimens; (5) provides for

tracking, distribution, and testing of

reference /diagnostic pathology

specimens submitted through the data

and special handling system; (6)

provides molecular pathology,

histopathology, and ultrastructure

reference/diagnostic support and

epidemic aid to state and local health

departments, other federal agencies, and

national and international health

organizations.

Dated: October 16, 1997.

David Satcher,

Director.

[FR Doc. 97–28598 Filed 10–28–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 for opportunity

for public comment on proposed data

collection projects, the Substance Abuse

and Mental Health Services

Administration (SAMHSA) will publish

periodic summaries of proposed

projects. To request more information

on the proposed projects or to obtain a

copy of the data collection plans and

instruments, call the SAMHSA Reports

Clearance Officer on (301) 443–8005.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

PROPOSED PROJECT: Obligated Service

for Mental Health.

Traineeships: Regulations and

Forms—Extension—SAMHSA’s Center

for Mental Health Services (CMHS)

awards grants to institutions for training

instruction and traineeships in mental

health and related disciplines. Graduate

student recipients of these clinical

traineeships must perform service, as

determined by the Secretary to be

appropriate in terms of the individual’s

training and experience, for a length of

time equal to the period of support. The

clinical trainees are required to submit

the SMA 111, which ensures agency

receipt of a termination notice prior to

the end of support, and the SMA 111–

2, which is an annual report on

employment status and any changes in

name and/or address, to SAMHSA.

The annual burden estimates are as

follows: