Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34847

393(b)(2)(C) and 42 U.S.C. 300u–1), FDA

and the Fred Hutchinson Cancer

Research Center in Seattle, WA, have

jointly designed a study involving a

written survey to be completed by

women with a previous diagnosis of

endometrial cancer. The study will

evaluate the occurrence of menopausal

vasomotor symptoms (‘‘hot flashes’’)

among these women, and the extent to

which they have used HRT, either as

therapy for menopausal symptoms or for

other reasons. (‘‘Hormone replacement

therapy’’ means treatment with estrogen

alone or with a combination of estrogen

and progestogen.)

FDA estimates the burden of this survey

as follows:

ESTIMATED ANNUAL REPORTING BURDEN

No. of Respondents Annual Frequency per

Response Total Annual Responses Hours per Response Total Hours

575 1 575 .5 288

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

Dated: June 26, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–16884 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0186]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each proposed collection of

information and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a proposed survey of mammography

facilities to assess the impact of

proposed regulations required by the

Mammography Quality Standards Act of

1992 (the MQSA).

DATES: Submit written comments on the

collection of information by September

3, 1996.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Charity B. Smith, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1686.

SUPPLEMENTARY INFORMATION: Section

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

Reduction Act of 1995 (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide a 60-day notice in the

Federal Register concerning each

proposed collection of information.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c). To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

FDA Survey of Mammography Facilities

The MQSA of 1992 (Pub. L. 102–539)

has resulted in regulatory efforts by FDA

to ensure high quality standards for

mammography in the United States. In

the Federal Register of April 3, 1996 (61

FR 14856), FDA proposed final

regulations to implement these

standards. Interim regulations are

codified at 21 CFR 900. In connection

with this rulemaking, FDA proposes to

conduct a survey of facilities to

determine current operating costs and

procedures. The information to be

collected from the proposed survey

includes general provider

characteristics, equipment

characteristics, facility operating

procedures, personnel qualifications,

and costs of compliance with current

quality standards. This information is

necessary in order to ensure that costs

to affected facilities are minimized to

the extent consistent with maintenance

of high quality mammography services,

and that patient access to

mammography services is not

diminished as a result of agency action.

The proposed survey will be a onetime data collection effort. Surveys will

be mailed to 1,000 randomly selected

facilities. Facilities will be contacted by

telephone in order to respond to any

specific issues, or questions that may

arise. Responses will not be mandatory,

and no facility will be required to

respond. All responses will be kept

confidential, although a compilation of

data that does not reveal facility-specific

information will be made available

upon request to participants and to the

public. A toll-free telephone number

will be installed to allow respondents

the opportunity to call if specific issues

arise.

FDA estimates the burden of this onetime survey as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total Costs

Initial Contact by Telephone 1,000 1 1,000 0.083 83 $1,385

Compile Requested Information 702 1 702 1.0 702 $11,716
34848 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

ESTIMATED ANNUAL REPORTING BURDEN—Continued

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total Costs

Mail-in Response 200 1 200 0 N/A N/A

Telephone Followup 800 1 800 0.083 67 $1,118

Responses by Telephone Interview 480 1 480 0.5 240 $4,006

Mail-In Response After Receiving

Followup 22 1 22 0 N/A N/A

Total Burden 1,092 $18,225

There are no capital costs or continuing operating and maintenance costs associated with this survey. These burden estimates include the

time for reviewing instructions, searching existing data sources, gathering the data needed, and completing and reviewing the collection of information. The hour and cost burden estimates were derived from a pretest of nine randomly selected facilities.

Dated: June 26, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–16970 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0121]

Bayer Corp., et al.; Withdrawal of

Approval of 29 NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 29 new animal drug

applications (NADA’s). Twenty-four

NADA’s are held by Bayer Corp.,

Agriculture Division, Animal Health

(formerly Miles, Inc., Agriculture

Division, Animal Health Products),

three are held by Hubbard Milling Co.,

and one each is held by HoffmannLaRoche, Inc., and Ohmeda, Inc. The

firms notified the agency in writing that

the animal drug products are not being

manufactured or marketed and

requested that approval of the

applications be withdrawn. In a final

rule published elsewhere in this issue of

the Federal Register, FDA is amending

the animal drug regulations by removing

the entries which reflect approval of the

NADA’s.

EFFECTIVE DATE: July 15, 1996.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: The

sponsors of the applications listed in the

table in this document have informed

FDA that these animal drug products are

not being manufactured or marketed

and have requested that FDA withdraw

approval of the applications.

NADA no. Drug name Sponsor name and address

6–462 ....................................... Diethylcarbamazine tablets ................................................ Bayer Corp., Agriculture Division, Animal Health,

P.O. Box 390, Shawnee Mission, KS 66201.

10–540 ..................................... Calcium disodium edetate injection ................................... Do.

11–380 ..................................... Diethylcarbamazine powder ............................................... Do.

12–054 ..................................... Protokylol hydrochloride tablets and injection ................... Do.

12–103 ..................................... Triamcinolone tablets ......................................................... Do.

12–392 ..................................... Triamcinolone injection ...................................................... Do.

12–598 ..................................... Disophenol sodium injection .............................................. Do.

15–161 ..................................... Trichlorfon powder ............................................................. Do.

15–965 ..................................... Coumaphos Type A medicated article ............................... Do.

30–045 ..................................... Triamcinolone/neomycin sulfate ointment .......................... Do.

34–394 ..................................... Niclosamide tablets ............................................................ Do.

35–263 ..................................... Styrylpyridinium chloride/diethylcarbamazine (as base)

oral liquid.

Do.

45–287 ..................................... Coumaphos crumbles ........................................................ Do.

48–645 ..................................... Tylosin Type A medicated articles (5, 10, 20, and 40

grams per pound).

Hubbard Milling Co., 424 North Riverfront Dr., P.O.

Box 8500, Mankato, MN 56002–8500.

49–555 ..................................... Styrylpyridinium chloride/diethylcarbamazine control diet

HRH/MSD.

Bayer Corp.

91–628 ..................................... Diethylcarbamazine citrate syrup ....................................... Do.

93–372 ..................................... Chlortetracycline calcium complex Type A medicated articles.Hoffmann-LaRoche, Inc., Nutley, NJ 07110.

94–402 ..................................... Tylosin and sulfamethazine Type A medicated articles .... Hubbard Milling Co.

95–078 ..................................... Trichlorfon oral liquid .......................................................... Bayer Corp.

96–031 ..................................... Styrylpyridinium chloride/diethylcarbamazine citrate tablets.Do.

100–201 ................................... Trichlorfon paste ................................................................ Do.

100–356 ................................... Styrylpyridinium chloride/diethylcarbamazine control diet

HRH.

Do.

100–670 ................................... Niclosamide Type A medicated article .............................. Do.

101–078 ................................... Dichlorophene and toluene capsules ................................. Do.

120–327 ................................... Diethylcarbamazine chewable tablets ................................ Do.

120–670 ................................... Styrylpyridinium, diethylcarbamazine edible tablets .......... Do.