Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices 38413

meeting to obtain expert on opinion

whether the agency should allow topical

therapies to be made available for OTC

use. The advisory committee

recommended that women whose initial

episode of vulvovaginal candidiasis was

diagnosed and treated by a physician

could adequately self-treat their

condition without the supervision of a

health care provider. The first 7-day

intravaginal drug product for the

treatment of vulvovaginal candidiasis

was approved for OTC use in 1990; the

first 3-day product in 1995; and the first

single-dose product in 1997.

In the Federal Register of February

27, 1997 (62 FR 9024), the agency

published a notice entitled ‘‘Over-theCounter Human Drugs; Proposed

Labeling Requirements,’’ proposing a

standardized format for the labeling of

OTC drug products. This proposed

standardized format is frequently

referred to as the ‘‘Drug Facts Format.’’

The agency is developing this guidance

document on labeling for OTC drug

products for the treatment of vaginal

yeast infections in accordance with the

‘‘Drug Facts Format.’’

Labeling for OTC drug products for

the treatment of vaginal yeast infections

consists of three components: (1) The

carton, (2) the educational brochure,

and (3) the overwrap. With OTC drug

products, the agency believes that

labeling takes on the critical role of

providing information to the consumer.

Therefore, consumers must have

information that is easily understood to

allow for appropriate self-selection and

appropriate use of the product. Since

there are a variety of OTC products

currently available for the treatment of

vaginal yeast infections, and since in

most cases, the content to be

communicated in labeling is nearly

identical for each product, the labeling

for these products should convey a clear

and consistent message to the consumer.

The intent of the draft guidance is to

provide labeling guidance for all OTC

drug products for the treatment of

vaginal yeast infections.

The draft guidance represents the

agency’s current thinking on the

labeling of OTC topical drug products

for the treatment of vaginal yeast

infections. 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.

Interested persons may, on or before

October 14, 1998, submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. The draft

guidance document and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18879 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–116, HCFA–

416, HCFA–R–148, and HCFA–R–231]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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 this 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: Clinical

Laboratory Improvement Amendments

(CLIA) Application Form and

Supporting Regulations in 42 CFR

493.1—.2001; Form No.: HCFA–116

(OMB# 0938–0581); Use: These

certification requirements have been

established for any entity that performs

testing on human beings for diagnostic

or treatment purposes. If a laboratory

conducts relatively simple tests that are

categorized as waived or provider

performed microscopy test procedures

(PPMP), it must obtain a certificate of

waiver or certificate of PPMP. If the

laboratory conducts any tests outside of

these two categories, it must apply for

a certificate of compliance or certificate

of accreditation and initially obtain a

registration certificate. These certificates

ensure that laboratories are in

compliance with CLIA.; Frequency:

Biennially; Affected Public: Business or

other for profit, Not for profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 20,000.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Annual Early

and Periodic Screening, Diagnostic, and

Treatment Services (EPSDT)

Participation Report and Supporting

Regulations in 42 CFR 441.60; Form

No.: HCFA–416 (OMB# 0938–0354);

Use: States are required to submit an

annual report on the provision of

EPSDT services to HCFA pursuant to

section 1902(a)(43) of the Social

Security Act. These reports provide

HCFA with data necessary to assess the

effectiveness of State EPSDT programs.

It is also helpful in developing trend

patterns, national projections,

responding to inquiries, and

determining a State’s results in

achieving its participation goal.;

Frequency: Annually; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 56; Total

Annual Responses: 56; Total Annual

Hours: 1,568.

3. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Limitation on

Provider-Related Donations and Health

Care-Related Taxes; Limitations on

Payments to Disproportionate Share

Hospitals; Medicaid and Supporting

Regulations in 42 CFR 433.68, 433.74,

447.74 and 447.272; Form No.: HCFA–

R–148 (OMB# 0938–0618); Use: These

information collection requirements

specify limitations on the amount of

Federal financial participation available

for medical assistance expenditures in a

fiscal year. States receive donated funds

from providers and revenues are

generated by health care related taxes.

These donations and revenues are used

to fund medical assistance programs.;

Frequency: Quarterly; Affected Public:

State, Local, or Tribal Government;

Number of Respondents: 51; Total

Annual Responses: 51; Total Annual

Hours: #3,892.

4. Type of Information Request:

Revision of a currently approved

collection; Title of Information
38414 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

Collection: Medicare+Choice (M+C)

Providers Sponsored Organization

(PSO) Waiver Request Form and

Supporting Regulations in 42 CFR

422.370–422.378; Form Number:

HCFA–R–231; Use: The PSO waiver

request form is for use by PSO’s that do

not have a State risk-bearing entity

licence and that wish to enter into a

M+C contract with HCFA to provide

prepaid health care services to eligible

Medicare beneficiaries. HCFA will use

the information requested on this form

to determine whether the applicant is

eligible for a waiver of the state

licensure requirement for M+C

organizations as allowed under section

1855(a)(2) of the Social Security Act.;

Frequency: One-time.; Affected Public:

Business or other for-profit, Not-forprofit institutions, and Federal

Government.; Annual Number of

Respondents: 30.; Total Annual

Responses: 30.; Total Annual Hours

Requested: 300.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 98–19003 Filed 7–15–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Privacy Act of 1974; Report of Altered

Systems

AGENCY: Department of Health and

Human Services (HHS), Health Care

Financing Administration (HCFA).

ACTION: Notice of the global addition of

three new routine uses to designated

HCFA Systems of Records.

SUMMARY: HCFA is adding three

additional routine uses to the Systems

of Records specified in Appendix A.

These routine uses will permit HCFA to

disclose individual-specific information

for the purpose of combating fraud or

abuse in the health benefit programs

administered by HCFA and for other

compatible purposes. These new routine

uses will permit HCFA to make

disclosures as follows: (1) To a HCFA

contractor, including but not necessarily

limited to fiscal intermediaries and

carriers under title XVIII of the Social

Security Act, to administer some aspect

of a HCFA-administered health benefits

program, or to a grantee of a HCFAadministered grant program, which

program is or could be affected by fraud

or abuse, for the purpose of preventing,

deterring, discovering, detecting,

investigating, examining, prosecuting,

suing with respect to, defending against,

correcting, remedying, or otherwise

combating such fraud or abuse in such

program; (2) To another Federal agency

or to an instrumentality of any

governmental jurisdiction within or

under the control of the United States,

including any state or local government

agency, for the purpose of preventing,

deterring, discovering, detecting,

investigating, examining, prosecuting,

suing with respect to, defending against,

correcting, remedying, or otherwise

combating fraud or abuse in a health

benefits program funded in whole or in

part by Federal funds; and, (3) To any

entity that makes payment for or

oversees the administration of health

care services, for the purpose of

preventing, deterring, discovering,

detecting, investigating, examining,

prosecuting, suing with respect to,

defending against, correcting,

remedying, or otherwise combating

fraud or abuse against such entity or the

program or services administered by

such entity, subject to certain

conditions.

EFFECTIVE DATES: HCFA filed an altered

system report with the Chairman of the

Committee on Government Reform and

Oversight of the House of

Representatives, the Chairman of the

Committee on Governmental Affairs of

the Senate, and the Administrator,

Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), on June 29, 1998. The

proposed new routine uses will become

effective 40 days from the date the

altered system report is submitted to

Congress and to OMB or 30 days from

the publication of this notice, whichever

is later.

ADDRESSES: The public should address

comments to Phillip L. Brown, Director,

Division of Freedom of Information and

Privacy Office, C2–26–21, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850. Comments received will be

available for review at this location by

appointment, Monday through Friday 9

a.m.–3 p.m., eastern time zone.

FOR FURTHER INFORMATION CONTACT: Mr.

Nelson Berry, Director, Division of Data

Liaison and Distribution, Office of

Information Services, HCFA, N3–13–15,

7500 Security Boulevard, Baltimore,

Maryland 21244–1850. His telephone

number is (410) 786–0182.

SUPPLEMENTARY INFORMATION: We are

publishing this notice to inform the

public of our intent to add three routine

uses under which HCFA may release

information without the consent of the

individual to whom such information

pertains in order to prevent, deter,

discover, detect, investigate, examine,

prosecute, sue with respect to, defend

against, correct, remedy, or otherwise

combat fraud or abuse in the programs

HCFA administers. Each proposed

disclosure of information under these

routine uses will be evaluated to ensure

that the disclosure is legally

permissible, including but not limited to

ensuring that the purpose of the

disclosure is compatible with the

purpose for which the information was

collected. Also, HCFA will require each

prospective recipient of such

information to agree in writing to

certain conditions to ensure the

continuing confidentiality of the

information. More specifically, as a

condition of each disclosure under these

routine uses, HCFA will:

(a) Determine that no other Federal

statute specifically prohibits disclosure

of the information;

(b) Determine that the use or

disclosure does not violate legal

limitations under which the information

was provided, collected, or obtained;

(c) Determine that the purpose for

which the disclosure is to be made;

(1) Cannot reasonably be

accomplished unless the information is

provided in individually identifiable

form;

(2) Is of sufficient importance to

warrant the effect on or the risk to the

privacy of the individual(s) that

additional exposure of the record(s)

might bring;

(3) There is a reasonable probability

that the purpose of the disclosure will

be accomplished;

(d) Require the recipient of the

information to: