10574 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices

FDA’s estimates are based on actual

data collected from industry over the

past 3 years, where there has been an

average of 1,600 annual responses to

FDA from 145 respondents each year.

3. Export of Medical Devices—Foreign

Letters of Approval—21 U.S.C. 381(e)(2)

(OMB Control No. 0910–0264—

Reinstatement)

Section 801(e)(2) of the act (21 U.S.C.

381(e)(2)) provides for the exportation of

an unapproved device under certain

circumstances if the exportation is not

contrary to the public health and safety

and it has the approval of the foreign

country to which it is intended for

export.

Requesters communicate (either

directly or through a business associate

in the foreign country) with a

representative of the foreign government

to which they seek exportation, and

written authorization must be obtained

from the appropriate office within the

foreign government approving the

importation of the medical device.

The written authorization from the

foreign country is used by the Office of

Compliance, CDRH in determining if the

foreign country has any objection to the

importation of the device into their

country. In FY 95, the Office of

Compliance received approximately 800

requests from U.S. firms to export

medical devices under section 801(e)(2)

of the act. If approval letters from

foreign governments were not submitted

by the requesting firm, CDRH would

then have had to contact various

embassies (via telephone, for example)

to seek their approval, which would

have been time consuming and costly.

The respondents to this collection of

information are companies that seek to

export medical devices.

The foreign letters of approval are

submitted under a statutory information

collection requirement only. Because

there is no additional burden

attributable to a regulation, no burden

chart is included.

4. Agreement for Shipment of Devices

for Sterilization—21 CFR 801.150(a)(2)

and (e) (OMB Control No. 0910–0131—

Reinstatement)

Under sections 501(c) and 502(a) of

the act (21 U.S.C. 351(c) and 352(a)),

nonsterile devices that are labeled as

sterile but are in interstate transit to a

facility to be sterilized are adulterated

and misbranded. FDA regulations in

§ 801.150(a)(2) and (e) (21 CFR

801.150(a)(2) and (e)) establish a control

mechanism by which firms may

manufacture and label medical devices

as sterile at one establishment and ship

the devices in interstate commerce for

sterilization at another establishment, a

practice that facilitates the processing of

devices and is economically necessary

for some firms. Under § 801.150(a)(2)

and (e), manufacturers and sterilizers

may sign an agreement containing the

following: (1) Instructions for

maintaining accountability of the

number of units in each shipment; (2)

acknowledgment that the devices are

nonsterile, being shipped for further

processing; and (3) specifications for

sterilization processing.

This agreement allows the

manufacturer to ship misbranded

products to be sterilized without

initiating regulatory action and provides

FDA with a means to protect consumers

from use of nonsterile products. During

routine plant inspections, FDA normally

reviews agreements that must be kept

for 2 years after final shipment or

delivery of devices. To discontinue this

reporting and recordkeeping procedure

would place an economic hardship on

the industry and an additional burden

on FDA to monitor product in interstate

commerce for failure to comply with

adulteration and misbranding

provisions of the act.

The respondents to this collection of

information are device manufacturers

and contract sterilizers.

FDA estimates the reporting burden of

this collection of information as follows:

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents Annual Frequency per

Response

Total Annual Responses Hours per Response Total Hours

801.150 90 20 1,800 4 7,200

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

No burden has been estimated for the

recordkeeping requirement in

§ 801.150(a)(2) because these records are

maintained as a usual and customary

part of normal business activities. Under

5 CFR 1320.3(b)(2), the time, effort, and

financial resources necessary to comply

with a collection of information are

excluded from the burden estimate if

the reporting, recordkeeping, or

disclosure activities needed to comply

are usual and customary because they

would occur in the normal course of

activities.

FDA’s estimate of the burden is based

on actual data obtained from industry

during the past 3 years where there are

approximately 90 firms subject to this

requirement.

Dated: February 25, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5646 Filed 3–6–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

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 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.
Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Notices 10575

Proposed Project

Drug Pricing Program Reporting

Requirements (OMB No. 0915–0176)—

Extension, No Change—Section 602 of

Public Law 102–585, the Veterans

Health Care Act of 1992, enacted section

340B of the Public Health Service Act

(PHS Act), Limitation on Prices of Drugs

Purchased by Covered Entities. Section

340B provides that a manufacturer who

sells covered outpatient drugs to eligible

entities must sign a pharmaceutical

pricing agreement with the Secretary of

Health and Human Services in which

the manufacturer agrees to charge a

price for covered outpatient drugs that

will not exceed an amount determined

under a statutory formula.

Covered entities which choose to

participate in the section 340B drug

discount program must comply with the

requirements of section 340B(a)(5) of the

PHS Act. Section 340B(a)(5)(A)

prohibits a covered entity from

accepting a discount for a drug that

would also generate a Medicaid rebate.

Further, section 340B(a)(5)(B) prohibits

a covered entity from reselling or

otherwise transferring a discounted drug

to a person who is not a patient of the

entity.

Because of the potential for disputes

and/or audits involving covered entities

and participating drug manufacturers;

the HRSA Office of Drug Pricing

Program has developed an informal

dispute resolution process for

manufacturers and covered entities as

well as manufacturer guidelines for

audit of covered entities.

Audit guidelines: A manufacturer will

be permitted to conduct an audit only

when there is reasonable cause to

believe a violation of section 340B(a)(5)

(A) or (B) has occurred. The

manufacturer must submit a request for

an audit of a covered entity to the HRSA

Office of Drug Pricing Program. The

manufacturer must then submit an audit

work plan describing the audit to the

HRSA Office of Drug Pricing Program

for review. The manufacturer will

submit copies of the audit report to the

HRSA Office of Drug Pricing Program

for review and resolution of the

findings, as appropriate. The

manufacturer will also submit an

informational copy of the audit report to

the HHS Office of Inspector General.

Dispute resolution guidelines:

Because of the potential for audit and

other disputes involving covered

entities and participating drug

manufacturers, the HRSA Office of Drug

Pricing Program has developed an

informal dispute resolution process,

which can be used if an entity or

manufacturer is believed to be in

violation of section 340B. Prior to filing

a request for resolution of a dispute with

the HRSA Office of Drug Pricing

Program, the parties must attempt, in

good faith, to resolve the dispute. All

parties involved in the dispute must

maintain written documentation as

evidence of a good faith attempt to

resolve the dispute. If the dispute is not

resolved and dispute resolution is

desired, a party must submit a written

request for a review of the dispute to the

HRSA Office of Drug Pricing Program. A

committee appointed to review the

documentation will send a letter to the

party alleged to have committed a

violation. The party will be asked to

provide a response to or a rebuttal of the

allegations.

To date, there have been no requests

for audits, and no disputes have reached

the level where a committee review was

needed. As a result, the estimates of

annualized hour burden for audits and

disputes have been reduced to the level

shown in the table below.

Reporting requirement Number of

respondents

Responses

per

respondent

Total

responses

Hours/responseTotal burden

hours

Audits:

Audit request 1 ............................................................... 2 1 2 4 8

Audit workplan 1 ............................................................. 1 1 1 8 8

Audit report 1 .................................................................. 1 1 1 1 1

Entity response .............................................................. 1 1 1 16 16

Dispute resolution:

Mediation request .......................................................... 5 1 5 8 40

Rebuttal ......................................................................... 2 1 2 16 32

Total ........................................................................ 10 1.2 12 8.75 105

1Prepared by the manufacturer.

Recordkeeping requirement Number of

recordkeepers

Hours of

recordkeeping Total burden

Dispute records ........................................................................................ 8 .5 4

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: February 26, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–5560 Filed 3–6–97; 8:45 am]

BILLING CODE 4160–15–P

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Customer Survey of Entities Eligible To

Participate in the Drug Pricing

Program—New

Section 602 of the Veterans Health

Care Act of 1992 enacted Section 340B

of the Public Health Service (PHS) Act,

‘‘Limitation of Prices of Drugs

Purchased by Covered Entities.’’ This

section provides that a manufacturer

that sells outpatient drugs to covered