Federal Register / Vol. 65, No. 77 / Thursday, April 20, 2000 / Notices 21199

Poulsbo, Washington, and thereby

indirectly acquire North Sound Bank,

Poulsbo, Washington.

Board of Governors of the Federal Reserve

System, April 14, 2000.

Jennifer J. Johnson,

Secretary of the Board.

[FR Doc. 00–9885 Filed 4–19–00; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control And

Prevention

[60 Day–00–33]

Proposed Data Collections Submitted

for Public Comment and

Recommendations

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Centers for Disease Control and

Prevention (CDC) is providing an

opportunity for public comment on

proposed data collection projects. To

request more information on the

proposed projects or to obtain a copy of

the data collection plans and

instruments, call the CDC/ATSDR

Reports Clearance Officer at (404) 639–

7090.

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

for other forms of information

technology. Send comments to CDC/

ATSDR Reports Clearance Officer, 1600

Clifton Road, MS–D24, Atlanta, GA

30333. Written comments should be

received within 60 days of this notice.

1. Proposed Projects

National Survey of Laboratory

Practices for Selected Coagulation Tests

in Hospital Laboratories—New—As part

of the continuing effort to support

public health objectives of treatment,

disease prevention and surveillance

programs, the Public Health Practice

Program Office (PHPPO), Division of

Laboratory Systems seeks to collect

information on coagulation testing

practices among U.S. hospital

laboratories. The purpose of this project

is to define the state of testing practices

in a random sample of up to 800 U.S.

hospital laboratories for selected

coagulation analytes by conducting a

questionnaire survey of these

laboratories. The objectives of this

survey are to collect data to assess the

variability of selected analytical and

non-analytical variables, such as normal

ranges, used for selected coagulation

tests. There has not been a systematic

and nationally based survey of

coagulation testing practices among U.S.

hospital laboratories. Such a

surveillance is needed due to the impact

that coagulation testing practices can

have on the diagnosis and management

of coagulation disorders.

There is ample evidence of variability

in coagulation testing practices based on

published literature corresponding to

experiences of individual institutions

that deal with analytical (e.g., impact of

instrument and kit reagents on

laboratory results) as well as preanalytical (such as specimen treatment)

and post-analytical (such as results

presentation) issues. However, there has

not been a systematic survey of national

hospital laboratories that has

documented the nature and extent of

such variability for selected coagulation

tests. Preliminary observations

document substantial inter-institutional

variability in coagulation testing

practices, with likely effect on patient

outcome.

This study will explore current

practices for one or more selected

coagulation tests to document the extent

and nature of variability in the testing

processes. It is anticipated that

information from this study will be used

for several purposes. First, results from

this project may be used in a future

study in order to surmise the potential

impact of various testing practices on

patient outcomes. A second anticipated

use of this study’s results is to

implement targeted laboratory

improvement efforts. Finally, this study

may form the basis for a future study to

assess the extent and nature of problems

in diagnosis and treatment of patients

caused by inaccurate laboratory results.

Because hypo- and hypercoagulability

disorders are prevalent in the U.S. and

they are defined to a great extent by

laboratory tests, a well designed

laboratory practice survey is expected to

be of great public health significance for

the nation.

We plan to sample up to 800

laboratories that perform selected

coagulation tests. The time required to

complete a survey will be

approximately 0.5 hours. We anticipate

that, of the respondents, approximately

80 will be Coagulation Laboratory

Directors (physicians) and

approximately 720 will be Coagulation

Laboratory Supervisors. The total

burden hours to complete the survey is

estimated to be 400. Based on hourly

wage estimates, the cost to respondents

could be approximately $9,000. Because

we expect the Laboratory Directors and

Supervisors to complete the survey

during their usual working hours. We

anticipate that there will be no actual

cost to the respondents.

ESTIMATES OF ANNUALIZED BURDEN HOURS

Type of respondents Number of

respondents

Frequency of

response

Average

time per

response

Annual hour

burden

Laboratory Director ........................................................................................................ 80 1 30/60 40

Laboratory Supervisor ................................................................................................... 720 1 30/60 360

Totals ............................................................................................................................. 800 ...................... ................ 400

21200 Federal Register / Vol. 65, No. 77 / Thursday, April 20, 2000 / Notices

Dated: April 13, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–9886 Filed 4–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 79N–0113; DESI 2847]

Parenteral Multivitamin Products;

Drugs for Human Use; Drug Efficacy

Study Implementation; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

conditions for marketing an effective

adult parenteral multivitamin drug

product that published in the Federal

Register of September 17, 1984 (49 FR

36446). The agency is notifying

manufacturers of modifications in the

adult formulation and certain portions

of the labeling for the products.

DATES: Supplements to approved new

drug applications (NDA’s) and

abbreviated new drug applications

(ANDA’s) are due on or before June 19,

2000.

ADDRESSES: Communication in response

to this notice should be identified with

the reference number DESI 2847 and

directed to the attention of the

appropriate office named below.

Supplements to full NDA’s (identify

with NDA number): Division of

Metabolic and Endocrine Drug

Products (HFD–510), Center for

Drug Evaluation and Research,

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857.

Original ANDA’s: Office of Generic

Drugs (HFD–600), Center for Drug

Evaluation and Research, Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

Requests for opinion of the

applicability of this notice to a

specific product: Division of

Prescription Drug Compliance and

Surveillance (HFD–330), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 17, 1984 (49 FR 36446), FDA

announced the conditions for marketing

an effective parenteral multivitamin

preparation. The effective 12-vitamin

formulation set forth in the notice was

based on the clinical evaluation of a

guideline formulation recommended in

1975 by the American Medical

Association (AMA). The notice also

stated that, because parenteral

multivitamin products are used and

evaluated in patients with a variety of

disease conditions, future adjustments

to the formulation may be necessary.

On August 21, 1985, FDA’s Division

of Metabolic and Endocrine Drug

Products and the AMA’s Division of

Personal and Public Health Policy

sponsored a public workshop on

‘‘Multivitamin Preparations for

Parenteral Use.’’ At the workshop,

additional data from clinical testing of

the 1975 AMA formulation and a variety

of other data were presented and

discussed in light of available

information on parenteral vitamin

therapy. After examining the data, the

AMA–FDA workshop committee

recommended that the dosage of

vitamins B1, B6, C, and folic acid be

increased and that vitamin K be added

to the formulation. Based on a review of

the committee’s recommendations, the

Director of the Center for Drug

Evaluation and Research has concluded

that the 1975 AMA formulation for

parenteral multivitamins should be

modified to reflect the advice of the

committee.

Accordingly, this notice amends

portions of the section Conditions for

Approval and Marketing in the

September 17, 1984, notice as follows

(in accordance with current labeling

practice, amounts previously listed in

international units (IU) have been

converted to weights):

Paragraph 1(a)(i) is revised as follows:

1. Adult formulation (intended for

ages 11 and older)

Ingredient Amount per Unit Dose

Fat Soluble Vitamins

A (retinol) 1 milligram (mg)

D (ergocalciferol or cholecalciferol) 5 micrograms (μg)

E (alpha-tocopherol) 10 mg

K (phylloquinone) 150 μg

Water-Soluble Vitamins

C (ascorbic acid) 200 mg

Folic acid 600 μg

Niacin 40 mg

B2 (riboflavin) 3.6 mg

B1 (thiamine) 6.0 mg

B6 (pyridoxine) 6.0 mg

B12 (cyanocobalamin) 5 μg

Pantothenic acid 15.0 mg

Biotin 60 μg

2. Labeling conditions.

(a) The label must bear the statement

‘‘Rx only.’’

(b) Indication. Paragraph 2(b)(i)(a) is

revised as follows (This language may

be editorially adapted to a specific

product’s labeling, as appropriate.):

Adult. This formulation is indicated

as a daily multivitamin maintenance

dosage for adults and for children age 11

and above receiving parenteral