Federal Register / Vol. 62, No. 197 / Friday, October 10, 1997 / Notices 53009

practices outside public health settings

despite the fact that most STD cases are

seen in private health care settings. No

descriptive data currently exist that

allow the Centers for Disease Control

and Prevention to characterize partner

notification practices among the broad

range of clinical practice settings where

STDs are diagnosed, including acute or

urgent care, emergency room, or

primary and ambulatory care clinics.

The existing literature contains

descriptive studies of partner

notification in public health clinics, but

no baseline data exist as to the practices

of different physician specialties across

different practice settings.

The CDC proposes to fill that gap

through a national sample survey of

7300 office managers and physicians

who treat patients with STDs in a wide

variety of clinical settings; a 70%

completion rate is anticipated (n=5110

surveys). This survey will provide the

baseline data necessary to characterize

infection control practices, especially

partner notification practices, for

syphilis, gonorrhea, HIV, and chlamydia

and the contextual factors that influence

those practices. Findings from the

proposed national survey of office

managers and physicians will assist

CDC to better focus STD control and

partner notification program efforts and

to allocate program resources

appropriately. Without this information,

CDC will have little information about

STD treatment, reporting, and partner

management services provided by

physicians practicing in the U.S. With

changes underway in the manner in

which medical care is delivered and the

move toward managed care, clinical

functions typically provided in the

public health sector will now be

required of private medical providers.

At present, CDC does not have sufficient

information to guide future STD control

efforts in the private medical sector.

Data collection will involve a mail

survey of practicing physicians. The

questionnaire mailing will be followed

by a reminder postcard after one week,

a second mailing to non-respondents at

three weeks, telephone follow-up with

non-respondents at five weeks, and a

final certified mailing of the survey to

non-respondents at eight weeks. A study

specific computerized tracking and

reporting system will monitor all phases

of the study. Receipt of the completed

questionnaire or a refusal will be logged

into this computerized control system to

ensure that respondents who return the

survey are not contacted with

reminders.

Estimated cost to respondents and

government based on an average pay

rate of $25/hour, the estimated total cost

burden for office managers to answer

Section 1 is $10,650. Based on an

average pay rate of $70/hour, the

estimated cost burden for physicians is

$94,640. Thus the total cost burden for

the data collection effort is estimated to

be $105,290.

Respondents Sections Number of

respondents

Number of

responses/

respondent

Average burden/response

(in hrs.)

Total burden

(in hrs.)

Office Managers ............................................................................. Section 1 7300 1 .08 584

Physicians ....................................................................................... Sections 2–4 5110 3 .03 460

Physicians ....................................................................................... Section 5–10 5110 6 .20 6132

Total ......................................................................................... ...................... ...................... ...................... ...................... 7176

Dated: October 6, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–26983 Filed 10–9–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–01–98]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Office on (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Projects

1. Prenatal HIV Prevention Survey:

Knowledge, Attitudes And Practices of

Health Care Providers Serving Pregnant

Women Regarding HIV Counseling and

Testing and the Use Of Zidovudine

(ZDV) During Pregnancy—New—This is

a new data collection. The purpose of

this survey is to assess the knowledge,

attitudes, and practices of health care

providers serving pregnant women

regarding HIV counseling and testing

and use of ZDV during pregnancy. Data

will be collected and reported to CDC to

describe:

(1) providers’ current practices in

providing prenatal care to HIV-infected

women, offering HIV counseling and

testing to pregnant women, and offering

ZDV to HIV-infected pregnant women;

(2) providers’ knowledge of the ACTG

076 results and PHS perinatal

transmission guidelines; (3) providers’

attitudes regarding HIV counseling and

testing of pregnant women; and, (4)

providers’ knowledge and experience in

the use of ZDV in treating HIV-infected

pregnant women.

The intended population to be

studied is physicians and nursemidwives providing prenatal care in

four areas (State of Connecticut,

potential population approximately 685;

State of North Carolina, potential

population approximately 1,500; Dade

County, FL, potential population

approximately 500; Brooklyn, NY,

potential population approximately 260)

where institutions are currently

conducting a CDC-funded study related

to implementation of the PHS

guidelines to prevent perinatal

transmission of HIV. The total annual

burden hours are 685.
53010 Federal Register / Vol. 62, No. 197 / Friday, October 10, 1997 / Notices

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burd

en/response

(in hrs.)

Census ................................................................................................................................................... 2,659 1 0.05

Questionnaire (Pilot Study) .................................................................................................................... 462 1 0.233

Questionnaire (Survey) .......................................................................................................................... 1,902 1 0.2333

2. Workshop Evaluation Component

of the CDC’s Prevention Marketing

Initiative Local Demonstration Site

Project—New—The Centers for Disease

Control and Prevention, National Center

for HIV, STD, and TB Prevention,

Division of HIV/AIDS Prevention,

Behavioral Intervention Research

Branch is planning to conduct a series

of studies as part of the evaluation of a

five-city HIV prevention demonstration

program. The program involves the

integration of social marketing strategies

and community participation in an

effort to develop and implement HIV

prevention activities.

Charged with developing programs for

those 25 years of age and younger,

community groups in the local

demonstration sites chose to segment

the target audience even further, and to

mount a variety of types of

interventions. Decisions about

segmentation and the nature of local

interventions were based on formative

research conducted in each community.

It is hoped that this demonstration

project will result in reductions in HIV

risk behavior among members of the

target audiences, as well as in enhanced

collaboration among individuals and

organizations in the participating

communities.

To evaluate the effectiveness of two

components of the intervention,

questionnaire data will be collected

from people under 25 years old and

from some parents in the demonstration

communities. These data will be

collected immediately before and after

the Skills-Building Workshops, one

month later, and six months later. In

addition, questionnaire data will be

collected once from individuals

contacted through Outreach programs.

These data will supplement a survey

(announced in the Federal Register on

8/27/96) designed to assess the full

program’s coverage of the target

population. Total annual burden hours

are 2,798.

Respondents Number of

respondents

Number of

responses/

respondents

Avg. burden/

response

(in hrs.)

Parental consent .................................................................................................................................... 1845 1 0.083

Teen consent/assent .............................................................................................................................. 23,168 1 0.0833

Pre/post questionnaire (intervention group) ........................................................................................... 31,584 2 0.3333

Post questionnaire (control group) ......................................................................................................... 31,584 1 0.3333

Follow-up questionnaire ......................................................................................................................... 42,640 1 0.3333

1 528 (ultimately needed per site) × 2 sites (whose target audiences are underage) plus 317 (3⁄5 × 528 for the one site that has not received

IRB permission to waive parental consent and will train underage youth and some 18 and 19 year olds). 2 528 × 5 sites × 1.2 (to allow for 20% loss to follow-up). 3 1⁄2 × 3,168. 4 529 × 5.

3. Preventive Health and Health

Services Block, Annual applications and

reports—(0920–0106)—Extension—In

1994, OMB approved the collection of

information provided in the grant

applications and annual reports for the

Preventive Health and Health Services

Block Grant (0920–0106). This approval

expires on September 30, 1997. CDC is

requesting extension of OMB clearance

for this legislatively mandated

information collection.

The information collected through the

applications from the official State

health agencies is required from section

1905 of the Public Health Service Act.

This is no change in the proposed

information collection from previous

years. The information collected from

the annual reports is required by section

1906, specifically the requirement for

uniform data sets matching the uses of

funds. Minor modifications to some

individual uniform data sets for chronic

diseases, as well as some other program

areas, have been made to maintain

consistency with performance measures

developed as a result of the Government

Performance and Results Act. Overall,

this request reflects a 25% reduction in

the collection burden to the grantees

(States). The total burden hours are

5490.

Respondents Number of

respondents

Number of

responses/

respondents

Avg.

burden/

response

(in hrs.)

Annual Applications .................................................................................................................................. 61 1 30

Annual Reports ......................................................................................................................................... 61 1 60
Federal Register / Vol. 62, No. 197 / Friday, October 10, 1997 / Notices 53011

Dated: October 3, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–26984 Filed 10–9–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0115]

SEF, P.A.; Revocation of U.S. License

No. 1166

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 1166) and the product

licenses issued to SEF, P.A., doing

business as National Health Guard, Inc.,

for the manufacture of Whole Blood and

Red Blood Cells (RBC’s). SEF, P.A., did

not respond to a notice of opportunity

for a hearing on a proposal to revoke its

licenses.

DATES: The revocation of the

establishment license (U.S. License No.

1166) and the product licenses is

effective October 10, 1997.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

revoking the establishment license (U.S.

License No. 1166) and product licenses

issued to SEF, P.A., doing business as

National Health Guard, Inc., 1885 West

Commercial Blvd., suite 140, Fort

Lauderdale, FL 33309, for the

manufacture of Whole Blood (CPDA–1)

and RBC’s including frozen,

deglycerolized, frozen rejuvenated, and

rejuvenated deglycerolized RBC’s.

On February 13, 1996, FDA attempted

to inspect the SEF, P.A., facility located

at 1820 North University Dr., Plantation,

FL. The facility was found to be vacant.

A visit that same day to the firm’s

previous business address, 1885 West

Commercial Blvd., suite 140, Fort

Lauderdale, FL, found that location to

be vacant as well. On February 28, 1996,

the owner of SEF, P.A., stated that all

the firm’s equipment was stored in a

warehouse in Miami, FL. The owner

also indicated that he would voluntarily

surrender the firm’s license because

SEF, P.A. was no longer in operation

and there were no plans to resume

operations. On June 17, 1996, FDA

successfully contacted the owner by

telephone and he indicated that he no

longer desired to relinquish the license.

Further attempts to contact the owner

on July 2 and 29, 1996, were

unsuccessful. On both occasions,

messages were left with the answering

party that were never replied to by the

owner.

FDA sent a certified, return-receipt

letter dated November 1, 1996, to the

firm’s owner. The letter stated that

under 21 CFR 601.5(b) a license may be

revoked when the Commissioner of

Food and Drugs finds that: (1)

Authorized FDA employees after

reasonable efforts have been unable to

gain access to an establishment or a

location for the purposes of carrying out

an inspection, or (2) manufacturing of

products or of a product has been

discontinued to an extent that a

meaningful inspection or evaluation

cannot be made. The letter provided the

firm’s owner notice of FDA’s intent to

revoke U.S. License No. 1166 and

announced FDA’s intent to offer an

opportunity for a hearing.

Under 21 CFR 12.21(b), FDA

published in the Federal Register of

April 9, 1997 (62 FR 17193), a notice of

opportunity for a hearing on a proposal

to revoke the licenses of SEF, P.A. In the

notice, FDA explained that the proposed

license revocation was based on the

inability of FDA employees to conduct

a meaningful inspection of the facility

because it was no longer in operation

and noted that documentation in

support of the license revocation had

been placed on file for public

examination with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. The notice provided the firm 30

days to submit a written request for a

hearing and 60 days to submit any data

and information justifying a hearing.

The notice provided other interested

persons with 60 days to submit

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period,

prescribed in the notice of opportunity

for a hearing and in the regulation, may

not be extended. No comments were

received from any other parties.

Accordingly, under 21 CFR 12.38,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 1166) and the product

licenses issued to SEF, P.A. are revoked,

effective October 10, 1997.

Dated: September 25, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–26987 Filed 10–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Center for Research Resources

Special Emphasis Panel (SEP) meetings:

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 3, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 4, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 5, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. D.G. Patel, Scientific

Review Administrator, 6705 Rockledge Drive,

MSC 7965, Room 6018, Bethesda 20892–

7965, (301) 435–0820.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: November 7, 1997.

Time: 12:00 p.m.

Place: National Institutes of Health, 6507

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.