18138 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Release of Establishment Inspection

Report to the Inspected Establishment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is revising its policy regarding the

release of the Establishment Inspection

Report (EIR) to inspected

establishments. Effective April 1, 1997,

a copy of the narrative portion of the

EIR will be routinely provided to the

inspected establishment once the

agency determines that the inspection is

‘‘closed’’ as set forth in the regulations.

FOR FURTHER INFORMATION CONTACT:

Charles I. Ahn, Office of Regulatory

Affairs (HFC–132), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–5637.

SUPPLEMENTARY INFORMATION: Under the

Freedom of Information Act (FOIA) and

FDA’s regulations governing disclosures

as set out in part 20 (21 CFR part 20),

inspectional information, including the

list of inspectional observations (FDA–

483), EIR, and the agency’s

communication with the regulated

establishment, must be disclosed upon

request by any member of the public

unless exempt. When requested

according to established FOI

procedures, the agency has made the

inspection-related information available

to requestors in accordance with the

above statutory and regulatory

requirements. That is, the information

becomes releasable once the inspection

is deemed closed by the agency.

Establishments wishing to obtain a copy

of FDA’s inspection report of their own

establishment have been required to

follow the same procedure. A number of

industry associations have expressed

concern that copies of EIR’s may be

released to other requestors before the

inspected establishments receive the

copies they requested. Consequently,

these groups have approached the

agency to request that it provide a copy

of the EIR following an inspection of

their facilities.

The agency has considered this

request and determined that a copy of

the narrative portion of the EIR should

be routinely provided to the inspected

establishment once the agency

concludes that the inspection is closed.

For the purpose of this directive, the

term ‘‘closed’’ will have the same

meaning as it has under § 20.64(d)(3).

Dated: April 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–9529 Filed 4–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–51]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Government National Mortgage

Association, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: June 13, 1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Sonya K. Suarez, Government National

Mortgage Association, Office of Policy,

Program and Risk Management,

Department of Housing & Urban

Development, 451 7th Street SW., Room

6226, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Sonya K. Suarez, on (202) 708–2272

(this is not a toll-free number) for copies

of the proposed forms and other

available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting agencies concerning the

proposed collection of information to:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) Enhance the quality,

utility, and clarity of the information to

be collected; and (4) Minimize the

burden of the collection of information

on those who are to respond, including

through the use of appropriate

automated collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

This Notice also lists the following

information:

Title of Proposal: Issuer’s Monthly

Accounting Reports.

OMB Control Number: 2503–0004.

Description of the need for the

information and proposed use: Issuers

use these forms to report monthly on

their securities accounting. Information

is necessary to assure issuers are

performing pursuant to the terms of the

guaranty agreement and investors are

receiving all funds due them.

Agency form numbers: HUD 11710A,

1710B, 1710C, 11710D and 11710E.

Members of affected public: Business

or other for-profit and the Federal

Government.

Estimation of the total number of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response:

Reporting Burden:

Form 11710 Total respondents

Responses

per respondents

Total responsesHours response Total hours

A ............................................................................................ 620 656 406,437 *.012 4,877

B ............................................................................................ 10 12 120 .25 30

C ........................................................................................... 2 2 4 .16 .6

D ........................................................................................... 620 12 7,440 .25 1,860

E ............................................................................................ 620 24 14,880 .16 2,381

........................ 706 428,881 ........................ 9,149

*14.4 min. per response/60 min. per hour=.24 hrs. × .05=.012.