39880 Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0514]

Draft Guidance for Industry on

ANDA’s: Impurities in Drug

Substances; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘ANDA’s: Impurities

in Drug Substances.’’ This draft

guidance provides recommendations for

including information in abbreviated

new drug applications (ANDA’s) and

supporting drug master files on the

content and qualification of impurities

in drug substances produced by

chemical syntheses for both monograph

and nonmonograph drug substances.

DATES: Written comments on the draft

guidance may be submitted by

September 22, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’. Written requests for single

copies of the draft guidance for industry

should be submitted to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Submit

written comments on the draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert W. Trimmer, Office of Generic

Drugs, Center for Drug Evaluation and

Research (HFD–625), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–5848.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘ANDA’s:

Impurities in Drug Substances.’’ This

draft guidance provides information on

the following: (1) Qualifying impurities

found in the drug substance used for

ANDA via a comparison with impurities

found in the related United States

Pharmacopeia (USP) monograph,

scientific literature, or innovator

material; (2) qualifying impurities found

at higher levels in the drug substance

used for ANDA than found in the

related USP monograph, scientific

literature, or innovator material; (3)

qualifying impurities in the drug

substance used for ANDA which are not

found in the related USP monograph,

scientific literature, or innovator

material; and (4) threshold levels, below

which qualification is not needed.

This draft level 1 guidance is being

issued consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). The draft guidance

represents the agency’s current thinking

on the content and qualification of

impurities in drug substances produced

by chemical syntheses that are used in

generic drug products. 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

requirement of the applicable statute,

regulations, or both.

Interested persons may, on or before

September 22, 1998, submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19714 Filed 7–23–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–250,254]

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, 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 the 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare

Secondary Payer Information Collection

and Supporting Regulations 42 CFR

489.20; Form No.: HCFA–250,254 OMB

#0938–0214; Use: This questionnaire

will collect information from

beneficiaries on health insurance

coverage that is primary to Medicare.

This information is necessary in order

for HCFA to identify those Medicare

beneficiaries who have group health

insurance that would pay before

Medicare, resulting in savings to the

Medicare Trust Fund. Medicare

Secondary Payer (MSP) is essentially

the same concept known in the private

insurance industry as coordination of

benefits, and refers to those situations

where Medicare does not have primary

responsibility for paying the medical

expenses of a Medicare beneficiary.

HCFA contracts with health insuring

organizations, herein referred to as

intermediaries and carriers, to process

Medicare claims. HCFA charges its

Medicare intermediaries and carriers

with various tasks to detect MSP cases;

develops and disseminates tools to

enable them to better perform their

tasks; and monitors their performance in

achievement of their assigned MSP

functions. Because intermediaries and

carriers are also marketing health

insurance products that may have

liability when Medicare is secondary,

the MSP provisions create the potential

for conflict of interest. Recognizing this

inherent conflict, HCFA has taken steps

to ensure that its intermediaries and

carriers process claims in accordance

with the MSP provisions, regardless of

what other insurer is primary.

Frequency: One time only; Affected

Public: Individuals or Households;

Number of Respondents: 14,204,000;

Total Annual Responses: 14,204,000;

Total Annual Hours: 773,240.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, 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