Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices 30239

consistent with the proposed activities;

(5 points) and

4. The quality of the applicant’s plan

to focus the proposed program and

activities on communities that are at

high risk for HIV. (7 points)

E. Coordination With Other Programs

(Total 10 Points)

1. The extent to which the applicant

describes and documents intended

coordination with other national,

regional, State, and local governmental

and nongovernmental organizations and

HIV prevention providers, such as other

national agencies or organizations, State

and local health departments; (4 points)

2. The quality of the applicant’s plan

to ensure consistency with applicable

State and local comprehensive HIV

prevention community plans when

conducting activities at the State and

local levels; (4 points) and

3. The quality of the applicant’s plan

for communicating successful

approaches and ‘‘lessons learned’’ to

other organizations. (2 points)

F. Scientific, Theoretical, or Conceptual

Foundation (Total 10 Points)

1. The extent to which the program,

as described, has a clearly described and

sound scientific, theoretical, or

conceptual foundation; (5 points) and

2. The extent to which data, theory, or

conceptual framework convincingly

demonstrate that the proposed activities

are likely to meet the stated needs. (5

points)

G. Evaluation and Technical Assistance

(Total 15 Points)

1. The quality of the applicant’s

evaluation plan for monitoring the

implementation of proposed activities

and measuring the achievement of

program goals and objectives; (10

points) and

2. The quality of the applicant’s plan

for obtaining needed technical

assistance and staff training to support

the proposed program. (5 points)

H. Budget (Not Scored)

Extent to which the budget is

reasonable, itemized, clearly justified,

and consistent with intended use of

funds.

A fiscal Recipient Capability Audit

may be required of some applicants

before funds will be awarded.

H. Other Requirements

A. Reporting Requirements

Provide CDC with the original plus

two copies of:

1. Semiannual progress reports which

should document services provided and

problems encountered, with careful

attention to answering questions and

documenting accomplishments and

problems encountered in meeting

program objectives. Progress reports

should follow the OMB report format

(OMB 0920–0249) as indicated in the

application kit. In the third and final

year of the project, CDC will ask

recipients to report on their plans to

sustain the program in the event CDC

funding is not continued for another

project period;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial report and

performance report, no more than 90

days after the end of the project period.

Send all reports to: Julia Valentine,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Room

300, 255 East Paces Ferry Road, NE,

Mailstop E–15, Atlanta, GA 30305–

2209.

For descriptions of the following

Other Requirements, see Attachment I:

AR98–4 HIV/AIDS Confidentiality

Provisions

AR98–5 HIV Program Review Panel

Requirements

AR98–7 Executive Order 12372

Review

AR98–8 Public Health System

Reporting Requirements

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

AR98–14 Accounting System

Requirements

AR98–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

Public Health Service Act, Section

301(a) [42 U.S.C. 241(a)], 317(k)(2) [42

U.S.C. 247b(k)(2)], as amended. The

Catalog of Federal Domestic Assistance

Number is 93.939.

J. Where to Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Julia

Valentine, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 98043, Centers for

Disease Control and Prevention, Room

300, 255 East Paces Ferry Road, NE.,

Mailstop E–15, Atlanta, GA 30305–

2209, telephone (404) 842–6871; Email

address JXV1@CDC.GOV.

For program technical assistance,

contact Victor Barnes, M.D., Division of

HIV/AIDS Prevention—Intervention

Research and Support; National Center

for HIV, STD, and TB Prevention;

Centers for Disease Control and

Prevention (CDC), Mail Stop E–58,

Atlanta, GA 30333, telephone (404)

639–5200, E-mail address

VCB3@CDC.GOV.

See also the CDC homepage on the

Internet: http://www.cdc.gov.

Dated: May 28, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention.

[FR Doc. 98–14645 Filed 6–2–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0393]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by July 6,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Mark L. Pincus, Office of Information

Resources Management (HFA–80), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

1471.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the
30240 Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

MedWatch: FDA’s Medical Product

Reporting Program, Forms FDA 3500

and FDA 3500A (OMB Control Number

0910–0291—Reinstatement)

Under sections 505, 507, 512, 513,

515, and 903 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

355, 357, 360b, 360c, 360e, and 393) and

section 351 of the Public Health Service

Act (42 U.S.C. 262), FDA has the

responsibility to ensure the safety and

effectiveness of drugs, biologics, and

devices. Under section 502(a) of the act

(21 U.S.C. 352(a)), a drug or device is

misbranded if its labeling is false or

misleading. Under section 502(f)(2) of

the act, a drug or device is misbranded

if it fails to bear adequate warnings, and

under section 502(j), a drug or device is

misbranded if it is dangerous to health

when used as directed in its labeling. To

carry out its responsibilities under these

statutory provisions, the agency needs

to be informed whenever an adverse

event or product problem occurs. Only

if FDA is provided with such

information will the agency be able to

evaluate the risk, if any, associated with

the product, and take whatever action

necessary to reduce or eliminate the

public’s exposure to the risk through

regulatory action ranging from labeling

changes to the rare product withdrawal.

To ensure the marketing of safe and

effective products, certain adverse

events must be reported. FDA has

issued regulations requiring reporting of

adverse events and product problems

for human drugs, biologics, and devices

in 21 CFR 310.305, 314.80, 600.80,

803.30, 803.50, 805.53, and 803.56.

These regulations implement statutory

adverse event reporting requirements in

sections 505(k) and 512(l) of the act and

section 2125 of the Public Health

Service Act (42 U.S.C. 300aa-25).

To carry out these provisions for

mandatory reporting of adverse events

and product problems with human

drugs, biologics, and devices, and to

facilitate voluntary reporting for certain

other products that FDA regulates, two

very similar forms are used. These forms

replaced other forms previously used by

the agency, including Form FDA 1639.

Form FDA 3500A is used for mandatory

reporting. Form FDA 3500 is used for

voluntary (i.e., not mandated by law or

regulation) reporting of adverse events

and product problems by health

professionals.

Respondents to this collection of

information are health professionals;

hospitals and other health care

providers (i.e., nursing homes, etc.);

manufacturers of biologics, drugs, and

medical devices; user facilities;

distributors; and importers.

In a notice published in the Federal

Register of December 18, 1996 (61 FR

66673), FDA invited comments on

Forms FDA 3500 and FDA 3500A

(hereinafter referred to as the December

18, 1996, notice).

FDA received two comments in

response to the December 18, 1996,

notice, one from industry and one from

a trade association. Both comments

generally supported the reinstatement of

Form FDA 3500A and opposed any

major changes to the structure of the

form, since many manufacturers have

made investments in systems that

produce computer facsimiles of the

form. However, both comments

questioned the need for Form FDA

3417, the medical device ‘‘Baseline

Report,’’ saying that virtually all of the

information is or could be provided to

FDA on either the 3500A form or

through the medical device registration

and listing process.

FDA agrees that there is a redundancy

of certain data elements between the

MedWatch Form FDA 3500A, the

medical device baseline report, and the

medical device registration and listing

forms. The Center for Devices and

Radiological Health (CDRH) plans to

evaluate data collected under the

current medical device reporting (MDR)

program over the next 6 months. CDRH

will then attempt to redesign the forms

related to medical device reporting,

including parts of Form FDA 3500A.

The redesign will be presented in an

interactive fashion to industry and OMB

in late 1998. The redesigned forms will

be made available for public comment

in early 2001 and will be instituted in

late 2001, assuming that OMB approval

has been obtained.

Both comments disagreed with FDA’s

estimate of the hours per response for

medical device reports submitted on

Form FDA 3500A. One of the comments

correctly stated that the estimate of one

hour per response ‘‘may be about right

for the physical act of filling out the

form itself,’’ but felt it was ‘‘a gross

underestimate of the time necessary to

‘respond’’’ due to the number of hours

it takes to gather the information

required by the form. The comment

suggested that FDA’s original estimate

of 1 hour per response be changed to a

range of 1 to 5 hours, depending on the

complexity of the event. FDA agrees

with the comment’s statement that the

agency’s estimate accurately reflects the

time necessary to fill out the form;

however, the agency disagrees that the

estimate for Form 3500A should be

modified to cover the time necessary to

gather the required information, as this

burden has already been counted under

the medical device reporting

regulations. The burden placed on

medical device user facilities, importers,

distributors, and manufacturers to

investigate a report and compile the

necessary information to complete Form

FDA 3500A was included in a separate

burden estimate that was subjected to

public comment (see 60 FR 63578 at

63597) and approved by OMB (OMB

control number 0910–0059).

Accordingly, to avoid duplication,

FDA’s estimate for Form 3500A has

been intentionally limited to the time

needed for the actual completing of the

form.

This comment also stated that FDA’s

estimate did not account for the burden

of filing a supplemental MedWatch

report on Form FDA 3500A when more

information is obtained after the filing

of the original report. FDA disagrees

with the comment’s second criticism,

however. Supplemental MedWatch

reports are also filed on Form FDA

3500A. Although such supplemental

reports are not listed separately in the

burden chart, they are included as part

of the estimated total number of Form

FDA 3500A submissions for each

agency component.

The other comment argued that FDA’s

estimate was too low because it did not

include the burden of preparing and

submitting medical device baseline

reports on Form FDA 3417. FDA

disagrees with this comment. The

medical device baseline report is not

part of the MedWatch collection of

information (OMB control number

0910–0291) for which FDA is requesting

reinstatement. Rather, the medical

device baseline report is a separate

collection of information that has

already undergone public comment (see

60 FR 63578 at 63597) and received

OMB approval (OMB control number

0910–0059). As noted above, however,

FDA does plan to revise the medical

device baseline report form and other

medical device reporting forms to

eliminate duplication, and the agency

will seek public comment on the

revisions.

FDA estimates the burden of this

collection of information as follows:

Table 1.—Estimated Annual Reporting

Burden1
Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices 30241

Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

CBER:

Form FDA 3500 804 1 804 0.5 402

Form FDA 3500A 63 158.5 9,988 1.0 9,988

CDER:

Form FDA 3500 14,875 1 14,875 0.5 7,438

Form FDA 3500A 500 375 187,522 1.0 187,522

CDRH:

Form FDA 3500 2,807 1 2,807 0.5 1,404

Form FDA 3500A 39,889 2.05 81,928 1.0 81,928

CFSAN:

Form FDA 3500 646 1 646 0.5 323

Form FDA 3500A 0 0 0 1.0 0

Total Hours 289,005

Form FDA 3500 9,567

Form FDA 3500A 279,438

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Note: CBER = Center for Biologics Evaluation and Research; CDER = Center for Drug Evaluation and Research; CDRH = Center for Devices

and Radiological Health; CFSAN = Center for Food Safety and Applied Nutrition. Form FDA 3500 is for voluntary reporting; Form FDA 3500A is

for mandatory reporting.

As more medical products are

approved by FDA and marketed, FDA

expects that more reports will be

submitted. The figures in the table are

based on the average number of reports

received in FY 1996, adjusted for the

anticipated annual increase in reports.

The anticipated annual increase

in reports is based on the average

annual increase from 1993 to 1996.

There are zeroes in the CFSAN row for

Form FDA 3500A because mandatory

reporting using Form FDA 3500A is not

applicable to foods.

Dated: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14721 Filed 6–2–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Blood Products Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Blood Products

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on June 18, 1998, 8 a.m. to 5:30

p.m., and on June 19, 1998, 8 a.m. to 3

p.m.

Location: Doubletree Hotel, Plazas I

and II, 1750 Rockville Pike, Rockville,

MD.

Contact Person: Linda A. Smallwood,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3514, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 19516. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On June 18, 1998, the

committee will: (1) Hear updates on

hepatitis C recipient notification and

partner deferral of xenotransplantation

recipients; (2) discuss information

provided on the Blood Action Plan,

Immune Globulin Intravenous supply

issues, and Plasma Inventory Hold; and

(3) discuss and make recommendations

on standard testing for human

immunodeficiency virus (HIV) variants.

On June 19, 1998, the committee will:

(1) Discuss and make recommendations

on the review of clinical trial design for

Alpha-1-Proteinase Inhibitor; and (2)

review and discuss the draft report on

the intramural site visit of the

Laboratories of Hemostasis and Cellular

Hematology, Division of Hematology,

and the Laboratories of Hepatitis and

Molecular Virology, Division of

Transfusion Transmitted Diseases.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 9, 1998. Oral

presentations from the public will be

scheduled between approximately 2

p.m. and 3 p.m. on June 18, 1998, and

between 10:45 a.m. and 11:15 a.m. on

June 19, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 9, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

June 18, 1998, from 3 p.m. to 3:30 p.m.,

and on June 19, 1998, from 10:15 a.m.

to 10:45 a.m., the meeting will be closed

to permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). These portions of

the meeting will be closed to discuss

increased sensitivity of manufacturers’

tests for HIV variants and review of

clinical trial design for Alpha-1-

Proteinase Inhibitor. On June 19, 1998,

from 2 p.m. to 3 p.m., the meeting will

be closed to permit discussion where

disclosure would constitute a clearly

unwarranted invasion of personal

privacy (5 U.S.C. 552b(c)(6)). This

portion of the meeting will be closed to

discuss the draft report of the intramural

site visit.