63182 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

Petition For Administrative Stay of

Action—21 CFR Part 10.35 (OMB

Control Number 0910—0194)—

Reinstatement

Section 10.35 (21 CFR 10.35), issued

under the authority of section 701(a) of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 371(a)), sets forth the

format and procedures by which an

interested person may file a petition for

an administrative stay of action.

Respondents to this information

collection are interested persons who

choose to file a petition for an

administrative stay of action. Such a

petition must: (1) Identify the decision

involved; (2) state the action

requested—including the length of time

for which a stay is requested; and (3)

include a statement of the factual and

legal grounds on which the interested

person relies in seeking the stay. The

information provided in the petition is

used by the agency to determine

whether the requested stay should be

granted.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

10.35 7 1 7 100 700

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

The burden estimate for this

collection of information is based on

FDA’s experience with petitions for

administrative stay of action over the

past 3 years. Agency personnel

responsible for processing the filing of

petitions for administrative stays of

action estimate that seven such petitions

are received by the agency annually,

with each requiring approximately 100

hours of preparation time.

Dated: November 19, 1997

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30982 Filed 11–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 91N–0396]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by December

26, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Reports of Corrections and Removals

for Manufacturers, Importers, and

Distributors of Medical Devices (21 CFR

806.10 and 806.20).

In a final rule published in the

Federal Register of May 19, 1997 (62 FR

27183), FDA issued regulations

requiring that manufacturers, importers,

and distributors of medical devices

report promptly to FDA any corrections

or removals of a device undertaken to

reduce a risk to health posed by the

device or to remedy a violation of the

Federal Food, Drug, and Cosmetic Act

(the act) that could present a risk to

health. The collection of this

information is required by section 519(f)

of the act (21 U.S.C. 360i(f)). These

regulations will help FDA to protect the

public health by ensuring that the

agency has current and complete

information regarding those actions

taken to reduce risks to health caused by

devices. Reports of such actions will

improve the agency’s ability to evaluate

device-related problems and to take

prompt action against potentially

dangerous devices.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

806.10 880 1 880 10 8,800

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

806.20 440 1 440 10 4,400

1There are no capital costs or operating and maintenance costs associated with this collection of information.
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices 63183

In the final rule (62 FR 27183), the

agency requested comments on the

information collection provision of the

new regulation. The 60-day comment

period closed July 18, 1997. The agency

received four comments. Comments

received in response to the information

collection provisions stated that: (1) The

U.S. designated agent provisions should

be reinstated; (2) the definition of risk

to health is confusing and contradictory,

and it raises the threshold of reports of

corrective and removal actions to that of

a voluntary recall, and as such will de

facto result in the automatic

classification of these reports as recalls;

(3) FDA has underestimated the

reporting burden; and (4) the

recordkeeping requirements place

undue burden on industry.

FDA disagrees with these comments.

As discussed in the May 1997 final rule

requiring reports of corrections and

removals, FDA published a final rule

staying the U.S. designated agent

provisions of the medical device

reporting (MDR) rule in the Federal

Register of July 23, 1996 (61 FR 38346).

FDA stayed those provisions in

response to serious concerns on the part

of regulated industry that the agency

had not adequately considered the costs

to and administrative burden on foreign

firms. The same concerns apply to the

U.S. designated agent provision

included in the proposed rule to require

reports of corrections and removals (59

FR 13828, March 23, 1994). FDA

omitted that provision in the final rule

(62 FR 27183) to allow the agency to

continue to consider industry’s

concerns. The agency has not

announced its decision on whether it

will reinstate U.S. designated agent

provisions in MDR or the corrections

and removals rule, but intends to do so

in the future.

FDA does not believe that the

definition of ‘‘risk to health’’ in the

corrections and removals rule is

confusing or contradictory. The agency

and manufacturers have used this same

definition successfully under part 7 (21

CFR part 7), the voluntary recall rule,

for over 20 years. Moreover, by using

the definition of ‘‘risk to health’’ that

appears in the voluntary recall rule, the

agency believes that it has established

an appropriate threshold for requiring

reports of removals and corrections. The

definition the agency adopted in the

final rule is narrower than the one that

appeared in the proposed rule and

eliminates the burden on manufacturers

of having to report corrections of minor

or very remote health risks. Adoption of

this definition does not affect recall

procedures under part 7, which remain

voluntary.

The agency does not believe that the

reporting burden for reports of

corrections and removals has been

underestimated. The agency revised the

reporting and recordkeeping burden

estimate in the final rule upward based

on a review of voluntary reporting data

and industry complaint files. The

comments did not submit any specific

data as to what they believe to be the

true costs of the rule.

The agency disagrees with the

comment that recordkeeping

requirements place an undue burden on

industry. The statute requires

manufacturers to keep records of

corrections and removals that do not

meet the requirements for reporting. The

regulation implements this statutory

requirement. FDA believes that the

recordkeeping requirement of the

corrections and removals rule carries

out the statutory mandate and is

appropriately tailored to the agency’s

mission of protecting the public health.

The statute and the regulation require

reporting only of events, corrections,

and removals that are initiated to

address a public-health risk. FDA

believes that it has limited reporting

requirements to information necessary

to carry out its mission of protecting the

public health.

Dated: November 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–31063 Filed 11–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–59]

Submission for OMB Review:

Comment Request

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been 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 date: December

26, 1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should

refer to the proposal by name and/or

OMB approval number and should be

sent to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Reports Management Officer,

Department of Housing and Urban

Development, 451 7th Street SW.,

Washington, DC 20410, telephone (202)

708–2374. This is not a toll-free number.

Copies of the proposed forms and other

available documents submitted to OMB

may be obtained from Ms. Weaver.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35).

The Notice lists the following

information: (1) The title of the

information collection proposal; (2) the

office of the agency to collect the

information; (3) the OMB approval

number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

Reduction Act of 1995, 44 U.S.C. 35, as

amended.

Dated: November 20, 1997.

David S. Cristy,

Director, Information Resources, Management

Policy and Management Division.

Notice of Submission of Proposed

Information Collection to OMB

Proposal: Application for

Homeownership Assistance Under

Section 235 of the National Housing

Act.

Office: Housing.

OMB Approval Number: 2502–0190.

Description of the Need for the

Information and its Proposed Use: The

information collection will be used to

determine a homeowner’s eligibility for

and amount of financial assistance to be

provided under Section 235,

Homeowners Assistance Payments

Program.

Form Number: HUD–93100.