Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0373]

Agency Information Collection Activities: Proposed Collection;

Comment Request

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 FDA Recall Regulations under

21 CFR part 7. Recall guidelines set forth procedures to be used by

manufacturers and distributors or other responsible persons in

notifying or alerting health professionals or other persons of an

unreasonable risk of substantial harm to the public's health and

describe the procedures used or required by FDA in the recall process.

DATES: Submit written comments on the collection of information by

August 10, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should

be identified with the docket number found in brackets in the heading

of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 listed below.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

FDA Recall Regulations--Part 7 (21 CFR Part 7), Subpart C--(OMB

Control Number 0910-0249--Extension)

These regulations were established to provide guidance to

manufacturers on recall responsibilities. These responsibilities

include development of a recall strategy; providing complete details of

the recall reason, risk evaluation, quantity produced, distribution

information, firm's recall

[[Page 31503]]

strategy and a contact official; notifying direct accounts of the

recall and to provide recipients with a ready means of reporting to the

recalling firm; provide periodic status reports so FDA can assess the

progress of the recall. The recall provisions provide the information

necessary for FDA to monitor recalls and assess the adequacy of a

firm's efforts in a recall. It also permits FDA to evaluate whether a

recall has been completed in a manner which assures that unreasonable

risk of substantial harm to the public health has been eliminated. The

guidelines apply to all regulated products (i.e., food, including

animal feed; drugs, including animal drugs; medical devices, cosmetics;

and biological products intended for human use.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

----------------------------------------------------------------------------------------------------------------

Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

7.42 1,712 4 6,848 1.8 12,326

7.46 and 7.49 1,712 4 6,848 4 27,392

7.53 1,712 4 6,848 36 246,528

7.55(b) 1,712 4 6,848 2 13,696

Total 299,942

----------------------------------------------------------------------------------------------------------------

\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-15339 Filed 6-8-98; 8:45 am]

BILLING CODE 4160-01-F