Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45671

concentrate standard, and assays based

on vWF plasma standards may not be

appropriate to measure the potency of

concentrates; and published clinical

trials have not correlated the dosage of

specific products with clinical outcome.

The main goal of this workshop is to

address these concerns through

exchange of information about each of

these issues, through the participation

of the patient, industrial, medical,

scientific, and regulatory communities.

Workshop participants are asked to

present their positions, rationales, and/

or experiences regarding: (1) The

benefits and liabilities of using

ristocetin cofactor activity, or other

tests, to measure vWF activity; (2)

proposals for standardizing the potency

and dosage of vWF concentrates; and (3)

clinical trials to relate given dosage

regimen to clinical benefit. Information

presented at this workshop will assist in

product development and facilitate

licensure of safe and effective vWF

products.

Registration and Requests for Oral

Presentations: Fax registration

information (including name, title, firm

name, address, telephone, and fax

number), and written material and

requests to make oral presentations, to

the contact person by September 19,

1997. Registration at the site will be

done on a space available basis on the

day of the workshop beginning at 7:30

a.m. There is no registration fee for the

workshop.

If you need special accommodations

due to a disability, please contact Joseph

Wilczek at least 7 days in advance.

Transcripts: Transcripts of the

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

workshop at a cost of 10 cents per page.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22982 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0201]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Evaluation of Proposed OTC Label

Formats’’ (study A) and ‘‘OTC Label

Format Preference’’ (study B) has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 23, 1997 (62 FR

28482), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507) and 5 CFR 1320.12 ,

which provides for emergency

processing of the proposed collection of

information. OMB has approved the

information collection and has assigned

OMB control number 0910–0343. The

approval expires on November 30, 1997.

An agency may not conduct or sponsor,

and a person is not required to respond

to, a collection of information unless it

displays a currently valid OMB control

number.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22981 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0349]

Convenience Kits Interim Regulatory

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘Convenience Kits Interim Regulatory

Guidance.’’ The guidance is final and in

effect at this time. This guidance applies

to convenience kits and provides

guidance regarding FDA’s intent to

exercise enforcement discretion with

respect to premarket notification

requirements under the Federal Food,

Drug, and Cosmetic Act (the act), and

describes FDA’s intent to propose

rulemaking to exempt certain

convenience kits from premarket

notification requirements. The guidance

addresses the type of data needed by the

Center for Devices and Radiological

Health (CDRH) to decrease the number

of 510(k) submissions for convenience

kits, saving Office of Device Evaluation

(ODE) review resources. The agency is

inviting public comment on this

guidance.

DATES: Submit written comments on

this guidance at any time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Convenience Kits Interim Regulatory

Guidance’’ to the Office of Device

Evaluation, Center for Devices and

Radiological Health, Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the guidance.

Submit written comments on the

guidance to the contact person listed

below.

FOR FURTHER INFORMATION CONTACT:

Heather Rosecrans, Office of Device

Evaluation (HFZ–404), Center for

Devices and Radiological Health, Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance represents a final

document that describes a new

regulatory approach to be applied to

convenience kits that could result in a

decrease in the number of 510(k)

submissions for these devices and, in so

doing, will save FDA review resources.

Under section 510(k) of the act (21

U.S.C. 360(k)), first time marketers of

devices must submit a premarket

notification and obtain clearance for a

device before it can be lawfully

introduced into interstate commerce.

Many convenience kits that have been

subject to 510(k) review are comprised

of legally marketed devices that are

simply being assembled in kit form

strictly for the ‘‘convenience’’ of the

purchaser.

FDA believes that under certain

circumstances, premarket clearance for

convenience kits may not be necessary

to ensure protection of the public

health. Accordingly, FDA intends to

propose rulemaking to exempt certain,

specifically identified convenience kits

from the requirement of premarket

notification. Until such rule is in effect,

FDA intends to exercise enforcement

discretion regarding the requirement for
45672 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

premarket clearance for convenience

kits that have intended uses,

components, and processing methods

that are described in the guidance, and

where the assembler/manufacturer is

able to reasonably conclude that any

further processing of the kit and its

components does not significantly affect

the safety or effectiveness of any of its

components. The intent to exercise

enforcement discretion means that FDA

does not intend to take enforcement

action for the failure to submit

premarket notification for convenience

kits described in the guidance. In the

future, FDA intends to propose

rulemaking to formally exempt these

types of kits from the requirement of

premarket notification.

This guidance is effective

immediately.

The ‘‘Convenience Kits Interim

Regulatory Guidance’’ represents the

agency’s current thinking on premarket

notification regulatory strategy for

convenience kits. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Electronic Access

In order to receive the ‘‘Convenience

Kits Interim Regulatory Guidance’’

document via your fax machine, call the

CDRH Facts-On-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. At the first

voice prompt, press 1 to access DSMA

Facts, at the second voice prompt press

2, and then enter the document number

562 followed by the pound sign (#).

Then follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may do so by using the

World Wide Web (WWW). The Center

for Devices and Radiological Health

(CDRH) maintains an entry on the

WWW for easy access to information

including text, graphics, and files that

may be downloaded to a PC with access

to the Web. The CDRH home page is

updated on a regular basis and includes

the ‘‘Convenience Kits Interim

Regulatory Guidance’’ document, device

safety alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Convenience Kits Interim Regulatory

Guidance’’ is available on the medical

device reporting page at ‘‘http://

www.fda.gov/cdrh/ode/convkit.html’’.

A text only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select MEDICAL

DEVICES AND RADIOLOGICAL

HEALTH. From there select CENTER

FOR DEVICES AND RADIOLOGICAL

HEALTH for general information, or

arrow down for specific topics.

III. Request for Comments

Interested persons may, at any time,

submit to the contact person listed

above written comments regarding this

guidance.

Dated: August 21, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–22855 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–39]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Home Health

Medicare Conditions of Participation

(COP) Information Collection

Requirements (ICR’s) as outlined in

Regulation 42 CFR Part 484; Form No.:

HCFA–R–39 OMB #0938–0365; Use:

The ICR’s contained in 42 CFR part 484

outline Home Health Agencies Medicare

COP’s to ensure Home Health Agencies

meet Federal patient health and safety

requirements. Frequency: Annually;

Affected Public: Business or other forprofit, Not-for-profit institutions and

Federal Government; Number of

Respondents: 10,203; Total Annual

Responses: 10,203; Total Annual Hours:

86,008.

2. Type of Information Collection

Request: Reinstatement without change

of a previously approved collection for

which approval has expired; Title of

Information Collection: Negative Case

Action Review Process (NCA)/Annual

Report and Supporting Regulations 42

CFR 431.800; Form No.: HCFA—6401

OMB #0938–0300; Use: HCFA uses the

NCA reviews conducted by states to

assure that beneficiaries are not being

denied medical assistance that they are

eligible for and that recipients are being

given adequate and timely notice of

termination. The results of NCA reviews

are used by states and the Federal

Government to identify problem areas

and plan corrective action initiatives.

Frequency: Annually; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 51; Total

Annual Responses: 51; Total Annual

Hours: 6,770.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.