46980 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Notices

Federal Register in accordance with 21

CFR 25.40(c).

Dated: August 25, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–23588 Filed 9-4-97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0268]

Draft Guidance for Industry on

Submission of Documentation in Drug

Applications for Container Closure

Systems Used for the Packaging of

Human Drugs and Biologics;

Availability; Extension of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

November 14, 1997, the comment

period on the agency’s draft guidance

for industry entitled ‘‘Submission of

Documentation in Drug Applications for

Container Closure Systems Used for the

Packaging of Human Drugs and

Biologics.’’ FDA published a notice of

the availability of the draft guidance in

the Federal Register of July 15, 1997 (62

FR 37925). FDA is extending the

comment period in response to requests

from the industry for additional time to

review and comment on the draft

guidance.

DATES: Written comments by November

14, 1997. General comments on agency

guidance documents are welcomed at

any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Alan C. Schroeder, Center for Drug

Evaluation and Research (HFD–570),

5600 Fishers Lane, Rockville, MD

20857, 301–827–1050.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 15, 1997, FDA

published a notice announcing the

availability of a draft guidance for

industry entitled ‘‘Submission of

Documentation in Drug Applications for

Container Closure Systems Used for the

Packaging of Human Drugs and

Biologics.’’ The draft guidance discusses

information on container closure

systems used in packaging drugs that

manufacturers should provide to FDA’s

Center for Drug Evaluation and Research

in meeting regulatory requirements for

new drug applications, abbreviated new

drug applications, investigational new

drug applications, abbreviated antibiotic

applications, and supplements to these

applications, and to the Center for

Biologics Evaluation and Research in

meeting requirements for biologics

license applications and product license

applications. The notice invited

interested persons to submit written

comments on the draft guidance by

September 15, 1997.

FDA has received requests from

several industry sources for additional

time to review the draft guidance on

container closure systems. FDA has

considered these requests and is

extending the comment period for 60

days.

Interested persons may, on or before

November 14, 1997, submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: August 29, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23586 Filed 9–4–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–211]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. We are

requesting an emergency review because

the collection of this information is

needed prior to the expiration of the

normal time limits under OMB’s

regulations at 5 C.F.R. Part 1320, in

order for States to apply for funds to

enable them to initiate and expand the

provision of child health assistance to

uninsured, low-income children in an

effective and efficient manner that is

coordinated with other sources of health

benefits coverage for children. States are

able to use Title XXI funds for: (1)

Establishing or expanding a separate

child health insurance program, (2)

expanding Medicaid coverage, or (3)

through a combination of both. The

Agency cannot reasonably comply with

the normal clearance procedures

because public harm is likely to result

if normal clearance procedures are

followed.

HCFA is requesting that OMB provide

a Three Day review and a 180-day

approval.

Type of Information Collection

Request: New Collection; Title of

Information Collection: State Child

Health Plan; Form No.: HCFA–R–211;

Use: This template will enable states to

apply for funds to initiate and expand

the provision of child health insurance

to uninsured, low income children in a

effective and efficient manner that is

coordinated with other sources of health

coverage for children; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 56; Total

Annual Responses: 56; Total Annual

Hours: 8,960.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Laura Oliven, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: August 29, 1997.

William Broglie,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–23591 Filed 9–4–97; 8:45 am]

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