1462 Federal Register / Vol. 62, No. 7 / Friday, January 10, 1997 / Notices

Statement of Organization, Functions,

and Delegations of Authority

Part H, Chapter HF (Food and Drug

Administration) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (35 FR 3685, February 25,

1970, and 56 FR 29484, June 27, 1991,

as amended most recently in pertinent

part at 60 FR 65350, December 19, 1995)

is amended to reflect the realignment of

the Office of Health and Industry

Programs, Center for Devices and

Radiological Health (CDRH), Office of

Operations, in the Food and Drug

Administration (FDA).

The Immediate Office of the Director,

Office of Health and Industry Programs

will consist of two new staffs; the

Regulations Staff and the Staff College.

CDRH believes that the establishment of

these two new staffs within the

Immediate Office of the Director, Office

of Health and Industry Programs, will

increase visibility to important program

areas of the Center.

Under section HF–B, Organization:

1. Insert the following new

subparagraphs under paragraph Office

of Health and Industry Programs

(HFWG), Center for Devices and

Radiological Health (HFW), reading as

follows:

Program Operations Staff (HFWG–1).

Provides all necessary administrative

support to the Office.

Provides services to track the status of

on-going Office programs as well as all

incoming and outgoing congressional

and FDA or Center-tracked

correspondence.

Provides personnel computer support

to Office staff including the evaluation

of hardware and software, installation of

hardware and software and assistance in

resolving hardware and software

problems.

Responds to public and government

requests for information about medical

device and radiation-emitting products.

Serves as the Center Consumer Affairs

Representative.

Regulations Staff (HFWG–2). Advises

the Center Director and appropriate

Agency officials on FDA regulation

development responsibilities relating to

medical devices and radiological health

activities. Serves as the Center focal

point for liaison on regulations

development activities with the Office

of Chief Counsel.

Coordinates the development, review

and submission of Federal Register

publications for the Center. Prepares

position statements for the Center on

standards promulgated by other

organizations.

Staff College (HFWG–3). Develops

necessary training courses for Center

employees by providing continuing

education credits for selected programs;

providing live satellite teleconferences

and distance learning telecasts; and

coordinating and sponsoring a variety of

seminars and lectures.

Performs needs assessments and

develops training objectives. Designs

courses and course evaluations.

2. Prior Delegations of Authority.

Pending further delegations, directives,

or orders by the Commissioner of Food

and Drugs, all delegations of authority

to positions of the affected organizations

in effect prior to this date shall continue

in effect in them or their successors.

Dated: December 13, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–578 Filed 1–9–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

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

Black Lung Clinic Program Regulatory

Requirements (42 CFR 55a) (OMB No.

0915–0081) Extension/No Change—The

purpose of the Black Lung Clinics

Program (BLCP) is to stimulate and

encourage local public and private

agencies to improve the health status of

coalworkers and to increase

coordination with other programs to

assist the coalworkers population. The

goal of the BLCP is to provide services

to minimize the effects of respiratory

and pulmonary impairments of coal

miners. Grantees provide specific

diagnostic and treatment procedures

required in the management of problems

associated with black lung disease

which improve the functional status,

i.e., ‘‘quality of life’’, of the miner and

reduce economic costs associated with

morbidity and mortality arising from

pulmonary diseases.

This request is for approval of the

reporting and recordkeeping

requirements in program regulations as

follows:

1. 42 CFR 55a.201 and 55a.301—

Reporting—Grantees must submit

applications for continued grant

support. The regulations outline the

requirements for grant applications for

States (55a.201) and for entities other

than States (55a.301).

2. 42 CFR 55a.201 (a) (3)—

Recordkeeping—The regulations require

that grantees conduct outreach to active

and inactive miners, which requires

maintenance of a register of persons

with pulmonary impairments.

3. 42 CFR 55a.201 (a) (4)—

Recordkeeping—The regulations require

that individual patient care plans be

provided for all patients. This includes

development and periodic updating of

the patient plans.

Estimates of annualized hour burden

are as follows:

Regulatory requirement 1

Number of

recordkeepers

Annual

hours per

recordkeeper

Total

burden

55a.201(a)(3)—patient registry ................................................................................................................ 14 357 5,000

55a.201(a)(4)—development of patient plans .......................................................................................... 14 1,214 17,000