67274 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 91N–0396]

Medical Devices; Reports of

Corrections and Removals; Stay of

Effective Date of Information

Collection Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Stay of effective date of a final

regulation.

SUMMARY: The Food and Drug

Administration (FDA) is staying the

effective date of the information

collection requirements of a final rule to

implement the provisions of the Safe

Medical Devices Act of 1990 (the

SMDA) regarding reports of corrections

and removals of medical devices. FDA

is taking this action because the

information collection requirements in

the final rule have not yet been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA). In the

Federal Register of November 26, 1997,

FDA announced that it sent the

proposed information collection to OMB

for review and clearance.

DATES: Effective November 17, 1997,

sections 806.10 and 806.20, which

contain information collection

requirements published at 62 FR 27183,

May 19, 1997, are stayed pending OMB

clearance of the information collection

requirements. FDA will announce the

effective date of these sections in the

Federal Register.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–215),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 19, 1997 (62 FR

27183), FDA issued a final rule

implementing the provisions of the

SMDA concerning reports of corrections

and removals of medical devices. The

rule was scheduled to become effective

on November 17, 1997. In the preamble

to the final rule, FDA provided for a 60-

day comment period on the information

collection requirements of the rule

under the Paperwork Reduction Act of

1995 (44 U.S.C. 3507), which was

enacted after the publication of the

proposed rule on reports of corrections

and removals of medical devices.

In the preamble to the final rule, FDA

announced that it would review the

comments received, make revisions as

necessary to the information collection

requirements, and submit the

requirements to OMB for approval. FDA

received four comments and has

reviewed and responded to them and

has submitted the information

collection requirements to OMB for

approval. A notice published in the

Federal Register of November 26, 1997

(62 FR 63182), informs the public how

to address comments on the information

collection provisions to OMB.

The Administrative Procedure Act

and FDA regulations provide that the

agency may issue a regulation without

notice and comment procedures when

the agency for good cause finds that

such procedures are impracticable,

unnecessary, or contrary to the public

interest (5 U.S.C. 553(b)(3)(B); 21 CFR

10.40(e)(1)). FDA finds there is good

cause for dispensing with notice and

comment procedures on this

amendment to stay the effective date of

the information collection requirements

of the final rule on reports of corrections

and removals until such time as OMB

approves these requirements. Engaging

in notice and comment rulemaking is

unnecessary because the information

collection provisions cannot become

effective until such time as FDA obtains

OMB approval of them. Moreover,

notice and comment rulemaking is

impracticable and contrary to the public

interest in this case. There is not enough

time to solicit a new round of notice and

comment on the issue of establishing a

delayed effective date for these

information collection requirements

without further delaying the

implementation of this provision of the

SMDA. Dispensing with notice and

comment rulemaking provides that the

information collection requirements of

the reports of corrections and removals

rule will go into effect at the earliest

possible date after OMB review and

clearance. FDA will announce the

effective date of the information

collection requirements of the final rule

in a future issue of the Federal Register.

List of Subjects in 21 CFR Part 806

Corrections and removals, Medical

devices, Reporting and recordkeeping

requirements.

Therefore, under sections 201–903 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321–393) and under

authority delegated to the Commissioner

of Food and Drugs, §§ 806.10 and

806.20, published in the Federal

Register of May 19, 1997 (62 FR 27183),

are stayed until further notice.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33418 Filed 12–23–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Parts 120, 123, 124, 126, 127,

and 129

[Public Notice 2602]

Bureau of Political-Military Affairs;

Amendments to the International

Traffic in Arms Regulations

AGENCY: Department of State.

ACTION: Final rule.

SUMMARY: This rule amends certain

provisions of the International Traffic in

Arms Regulations (ITAR) in order to

reflect recent changes to the Arms

Export Control Act (AECA).

EFFECTIVE DATE: December 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Mary F. Sweeney, Compliance and

Enforcement Branch, Office of Defense

Trade Controls, Bureau of PoliticalMilitary Affairs, Department of State

(703) 875–6644.

SUPPLEMENTARY INFORMATION: Section

1045(a) of the National Defense

Authorization Act for Fiscal Year 1997

(Public Law 104–201) added a new

paragraph 12 to section 36(a) of the

AECA requiring a report on all

concluded agreements involving

coproduction or licensed production

outside of the United States of defense

articles of United States origin.

Section 141 of the Defense and

Security Assistance Improvements Act

of 1996 (Public Law 104–164) amended

and restated the requirements in section

36(c) and (d) of the AECA for

certification to Congress of certain

proposed exports and technical

assistance or manufacturing license

agreements, generally reducing the time

for transfers involving member

countries of the North Atlantic Treaty

Organization, Australia, Japan and New

Zealand.

Section 151 of Public Law 104–164

added a new clause (ii) to Subsection

(b)(1)(A) of section 38 of the AECA

requiring the registration and licensing

of persons who engage in the business

of brokering activities of defense articles

and defense services.

Section 156 of Public Law 104–164

amended section 38(e) of the AECA,

providing that certain types of

information shall not be withheld from

public disclosure unless the President