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.
63184 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Notices

Respondents: Individuals or

Households and Business or Other ForProfit.

Frequency of Submission: On

occasion.

Reporting Burden:

Number of respondents x Frequency of

response x Hours perresponse = Burdenhours

HUD–93100 .............................................................................. 21,000 1 25 250

Total Estimated Burden Hours: 5,250.

Status: Reinstatement, with changes.

Contact: Diane Lobasso, HUD, (202)

708–2700 x2191; Joseph F. Lackey, Jr.,

OMB, (202) 395–7316.

Dated: November 20, 1997.

[FR Doc. 97–31071 Filed 11–25–97; 8:45 am]

BILLING CODE 4210–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–60]

Submission of 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,

Southwest, 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: Description of materials.

Office: Housing.

OMB Approval Number: 2502–0192.

Description of the Need for the

Information and Its Proposed Use: Form

HUD–92005 is needed so that builders

and sponsors can describe the materials

for the construction and other

improvements to the single family

property. This form and the drawings

define the scope and limits of the

proposed construction. This information

is also used by HUD to estimate the

value for FHA mortgage insurance to

determine if the construction meets

regulatory requirements.

Form Number: HUD–92005.

Respondents: Business or Other ForProfit and the Federal Government.

Frequency of Submission: On

occasion.

Reporting Burden:

Number of respondents x Frequency of

response x Hours per response = Burdenhours

HUD–92005 ................................................................................ 2,500 20 .5 25,000