Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 / Notices 35937

B. Cost Recovery

CERCLA, as amended by SARA,

provides for the recovery of costs

incurred for response actions at each

Superfund site from potentially

responsible parties. The recipient would

agree to maintain an accounting system

that will keep an accurate, complete,

and current accounting of all financial

transactions on a site-specific basis, i.e.,

individual time, travel, and associated

cost including direct cost, as

appropriate for the site. The recipient

would also maintain documentation

that describes the site-specific response

actions taken with respect to the site,

e.g., contracts, work assignments,

progress reports, and other documents

that describe the work performed at a

site. The recipient will retain the

documents and records to support these

financial transactions and

documentation of work performed, for

possible use in a cost recovery case, for

a minimum of ten years after

submission of a final financial status

report, unless there is litigation, claim,

negotiation, audit or other action

involving the specific site, then the

records will be maintained until

resolution of all issues on the specific

site.

C. Third Party Agreements

Project activities which are approved

for contracting pursuant to the prior

approval provisions shall be formalized

in a written agreement that clearly

establishes the relationship between the

grantee and the third party. The written

agreement shall at a minimum:

1. State or incorporate by reference all

applicable requirements imposed on the

contractors under the grant by the terms

of the grant, including requirements

concerning technical review (ATSDR

selected reviewers), release of data,

ownership of data, and the arrangement

for copyright when publications, data or

other copyrightable works are

developed under or in the course of

work under a PHS grant supported

project or activity.

2. State that any copyrighted or

copyrightable works shall be subject to

a royalty-free, non-exclusive, and

irrevocable license to the Government to

reproduce, publish, or otherwise use

them, and to authorize others to do so

for Federal Government purposes.

3. State that whenever any work

subject to this copyright policy may be

developed in the course of a grant be a

contractor under a grant, the written

agreement (contract) must require the

contractor to comply with these

requirements and can in no way

diminish the Government’s right in that

work.

4. State the activities to be performed,

the time schedule for those activities,

the policies and procedures to be

followed in carrying out the agreement,

and the maximum amount of money for

which the grantee may become liable to

the third party under the agreement. The written agreement required shall

not relieve the grantee of any part of its

responsibility or accountability to

ATSDR under the cooperative

agreement. The written agreement shall,

therefore, retain sufficient rights and

control to the grantee to enable it to

fulfill this responsibility and

accountability.

Application Submission and Deadline

The original and two copies of

application PHS Form 5161–1 (OMB

Number 0937–0189) should be

submitted to Ron Van Duyne, Grants

Management Officer, Attn: Patrick A.

Smith, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 225 East Paces Ferry Road, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305-2209, on or before August 10,

1998. (By formal agreement, the CDC

Procurement and Grants Office will act

for and on behalf of ATSDR on this

matter.)

A. Deadline: Applications shall be

considered as meeting the deadline if

they are either: 1. Received on or before the deadline

date, or

2. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.) B. Late Applications: Applications

which do not meet the criteria in A.1.

or 2. above are considered late

applications. Late applications will not

be considered.

Where to Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked to leave your name,

address, and phone number and will

need to refer to ATSDR Announcement

Number 98095. You will receive a

complete program description,

information on application procedures,

and application forms. CDC will not

send application kits by facsimile or

express mail. If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Patrick

A. Smith, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mail Stop E–13, Atlanta, GA

30305–2209, telephone (404) 842–6803,

Internet: phs3@cdc.gov.

Programmatic technical assistance

may be obtained from Rueben C.

Warren, DDS, MPH, DrPH, Associate

Administrator for Urban Affairs, Agency

for Toxic Substances and Disease

Registry, 1600 Clifton Road, N.E., Mail

Stop E–29, Atlanta, GA 30333 or by

calling (404) 639–5060, Internet:

rcw4@cdc.gov.

Please refer to announcement number

98095 when requesting information and

submitting an application.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the INTRODUCTION through the

Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325

(Telephone 202–783–3238).

This and other CDC announcements

are available through the CDC homepage

on the Internet. The address for the CDC

homepage is: http://www.cdc.gov.

Dated: June 25, 1998.

Georgi Jones,

Director, Office of Policy and External Affairs

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 98–17459 Filed 6–30–98; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0525]

Draft Guidance for Industry:

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs);’’ Reopening of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening until

July 31, 1998, the comment period for
35938 Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 / Notices

a notice announcing the availability of

a draft guidance for industry entitled

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’ that appeared in the Federal

Register of January 5, 1998 (63 FR 236).

FDA is taking this action because of the

complexity and importance of the issues

raised by this draft guidance and to

allow interested parties additional time

to prepare and submit comments.

DATES: Written comments by July 31,

1998. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of the draft guidance

for industry are available on the Internet

at http://www.fda.gov/cder/guidance/

index.htm. Submit written requests for

single copies of the draft guidance for

industry ‘‘Promoting Medical Products

in a Changing Healthcare Environment;

I. Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’ to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your request.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Regarding prescription drugs: Laurie

B. Burke, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–2828, or via

Internet at burkel@cder.fda.gov;

Regarding prescription biological

products: Toni M. Stifano, Center

for Biologics Evaluation and

Research (HFM–200), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–827–3028, or via

Internet at stifano@cber.fda.gov;

Regarding restricted medical devices:

Byron L. Tart, Center for Devices

and Radiological Health (HFZ–302),

Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–4639, or via

Internet at bxt@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 5, 1998 (63

FR 236), FDA published a notice

announcing the availability of a draft

guidance for industry entitled

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs).’’ The draft guidance is intended

to assist sponsors of regulated medical

products (human drugs, biologics, and

medical devices) by describing

circumstances in which they may be

held responsible for promotional

activities performed by a healthcare

organization/PBM subsidiary or by a

nonsubsidiary healthcare organization/

PBM that violate the Federal Food,

Drug, and Cosmetic Act and regulations

issued thereunder. The draft guidance

also reminds medical product sponsors

of their responsibility to submit or, in

the case of some devices, maintain

historical files of promotional labeling

and advertising. Following the review of

all comments received between January

5 and July 31, 1998, the agency intends

to solicit public comment on a new draft

guidance document.

Interested persons may, on or before

July 31, 1998, submit to the Dockets

Management Branch (address above)

written comments on this subject. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: June 25, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17413 Filed 6-30-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions

and Delegations of Authority

This notice amends Part R of the

Statement of Organization Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (HRSA), (60 FR

56605 as amended November 6, 1995, as

last amended at 63 FR 33379–80 dated

June 18, 1998). This notice reflects the

changes in the Bureau of Primary Health

Care (BPHC), Division of National

Health Service Corps.

I. Under Division of National Health

Service Corps (RC5) delete the current

functional statement in it’s entirety and

replace with the following:

Provides (1) strategic planning and

overall policy guidance, and program

oversight to the National Health Service

Corps (NHSC); (2) initiates national

program and policy changes, including

regulatory and statutory amendments, as

necessary, to ensure NHSC consistency

with evolving national health care

policy; (3) supports the NHSC National

Advisory Council (NAC), which advises

the Secretary, DHHS, on national health

care policy, particularly as it affects

health manpower issues and the NHSC;

(4) works with the Office of the

Administrator and the Office of the

Secretary to ensure that the NAC

membership are nationally recognized

leaders in national health care policy

issues, and in their respective primary

health care disciplines; (5) provides

national NHSC leadership, integration

and coordination with BPHC, HRSA and

other Departmental programs serving or

impacting the Nation’s underserved

communities and populations; (6) works

directly with Bureau, Agency and intraAgency, Departmental, and interDepartmental organizations and staffs,

as appropriate, on national policies and

strategies affecting underserved

populations and development and

distribution of primary care clinical

personnel; (7) coordinates with the

Bureau of Health Professions regarding

health professionals education and

training, as appropriate; (8) speaks for

NHSC with national, regional, State, and

local public and private health care

professional associations, universities

and other health professions training

institutions and other groups whose

public policy interests relate to primary

health care manpower and access

issues; (9) articulates NHSC policy

interests and issues to a variety of

national forums, including universities,

foundations, think tanks, and other

organizations whose interests in

primary and other health care public

policy issues have potential for affecting

the NHSC; (10) provides policy

guidance and support to HRSA field

offices, and to State and Regional

Primary Care Offices and Primary Care

Associations; and (11) coordinates

NHSC and Bureau policy on primary

and other health care manpower issues,

and works with a wide variety of

national, regional, State and local

constituencies in ensuring their

effective implementation.