Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Notices 67879

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0131. The

approval expires on November 30, 2000.

Dated: December 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33798 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0048]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled,

‘‘Sterility Requirements for Inhalation

Solution Products’’ has been approved

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 23, 1997

(62 FR 49638), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has approved the information

collection and has assigned OMB

control number 0910–0353. The

approval expires on November 30, 2000.

Dated: December 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33799 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N–0251]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Electronic Records; Electronic

Signatures’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 20, 1997 (62 FR

33660), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0303. The

approval expires on August 31, 2000.

Dated: December 17, 1997

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33801 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97D–0483]

Draft Guidance for Industry on FoodEffect Bioavailability and

Bioequivalence Studies; 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 ‘‘Food-Effect

Bioavailability and Bioequivalence

Studies.’’ The draft guidance is intended

for sponsors of new drug applications

(NDA’s), abbreviated new drug

applications (ANDA’s) and abbreviated

antibiotic applications (AADA’s) who

intend to conduct food-effect

bioavailability (BA) and bioequivalence

(BE) studies for oral immediate release

and modified release dosage forms. The

guidance provides information and

recommendations on study design, data

analysis, and labeling.

DATES: Written comments may be

submitted on the draft guidance by

March 2, 1998. General comments on

the agency guidance documents are

welcome at any time.

ADDRESSES: Submit written requests for

single copies ‘‘Food-Effect

Bioavailability and Bioequivalence

Studies’’ to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFD–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Ameeta Parekh, Center for Drug

Evaluation and Research (HFD–860),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5325.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘FoodEffect Bioavailability and

Bioequivalence Studies.’’ The draft

guidance is intended to help sponsors of

NDA’s, ANDA’s, and AADA’s when

conducting BA and BE studies with

food for oral immediate release and

modified release dosage forms.

The intake of food is known to alter

gastrointestinal physiology, generally

delaying gastric emptying, stimulating

bile flow, altering the pH of gastric

environment and the blood flow to the

region. These factors can influence the

BA (important in new drug and

formulation situations) and BE

(important in switchability of drug

products) when drug products are

coadministered with food. Food also

may alter lumenal metabolism and can