Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Notices 50617

Board of Governors of the Federal Reserve

System, September 23, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–25660 Filed 9–25–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request; Proposed

Projects

Title: Refugee Resettlement Program

Estimates: CMA, ORR–1.

OMB No.: 0970–0030.

Description: ORR reimburses, to the

extent of available appropriations,

certain non-Federal costs for the

provision of cash and medical

assistance to refugees, along with

allowable expenses in the

administration of the Refugee

Resettlement Program. ORR needs

sound State estimates of likely

expenditures for refugee cash, medical,

and administrative (CMA) expenditures

so that it can anticipate Federal costs in

upcoming quarters. If Federal costs are

anticipated to exceed budget

allocations, ORR must take steps to

reduce Federal expenses, such as

limiting the number of months of

eligibility for Refugee Cash Assistance

(RCA) and Refugee Medical Assistance

(RMA).

To meet the need for reliable State

estimates of anticipated expenses, ORR

has developed a single-page form in

which States estimate the average

number of recipients for each category

of assistance, the average unit cost over

the next 12 months, and the expense for

the overall administration of the

program. This form, the ORR–1

(formerly Form FSA–601) must be

submitted prior to the beginning of each

Federal fiscal year. Without this

information, ORR would be out of

compliance with the intent of its

legislation and otherwise unable to

estimate program costs adequately.

In addition, the ORR–1 serves as the

State’s application for reimbursement of

its CMA expenses. Submission of this

form is thus required by section

412(a)(4) of the Immigration and

Nationality Act which provides that ‘‘no

grant or contract may be awarded under

this section unless an appropriate

proposal and application * * * are

submitted to, and approved by, the

appropriate administering official.’’

Respondents: State, Local or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

ORR–1 .............................................................................................................................. 24 1 .5 24

Estimated Total Annual Burden

Hours: 24

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Service,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments 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)

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 or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: September 22, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–25603 Filed 9–25–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96F–0493]

Gerard T. O’Brien; Denial Without

Prejudice of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is denying a

petition (FAP 7A4530) proposing that

the food additive regulations be

amended to provide for the safe use of

a mixture of hydrogen peroxide and

sodium bicarbonate as an antimicrobial

agent on fresh poultry. The petitioner

did not provide sufficient data and

information for the agency to conclude

that the proposed use of the food

additive is safe, or that it will have its

intended technical effect.

DATES: Written objections and request

for a hearing by October 27, 1997.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

James C. Wallwork, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204–

0001, 202–418–3078.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register on

January 2, 1997 (62 FR 101), FDA

announced that a food additive petition

(FAP 7A4530) had been filed by Gerard

T. O’Brien, 2162 Skyline Dr.,

Gainesville, GA 30501. The petitioner

requested that FDA amend the food

additive regulations to provide for the

safe use of a mixture of hydrogen

peroxide and sodium bicarbonate as an

antimicrobial agent on fresh poultry.

In acting on any food additive

petition, FDA must determine whether

the proposed use of the additive under

the conditions of use to be specified in

the regulation is safe (section

409(c)(3)(A) of the Federal Food, Drug,
50618 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Notices

and Cosmetic Act (the act) (21 U.S.C.

348(c)(3)(A))). The burden is on the

petitioner to submit to FDA data and

information that are adequate to provide

the basis for such a determination. The

data and information must include all

studies, whether favorable or adverse,

relevant to the safety of the food

additive and relevant to whether the

food additive will achieve its intended

physical or technical effect.

FAP 7A4530 was submitted to the

agency on September 24, 1987, as FAP

7A4045. The agency found that the

petition did not meet the minimum

requirements for filing in accordance

with § 171.1(c) (21 CFR 171.1(c)).

Despite FDA requests to petitioner for

data and information to correct the

deficiencies (Refs. 1, 2, and 3), the

petitioner failed to submit such data and

information to demonstrate that the food

additive will achieve its intended

technical effect, and that it is safe for the

intended use. Specifically, the

petitioner failed to provide data and

information to demonstrate that the

hydrogen peroxide and sodium

bicarbonate mixture would significantly

reduce pathogenic bacterial

contamination on the surface of fresh

poultry, e.g. Salmonella, Escherichia

coli, and psychrophiles. In addition, the

petitioner failed to provide data and

information on whether oxidative

effects of hydrogen peroxide occur on

poultry as a result of the proposed use.

Consequently, FDA requested that the

petitioner submit laboratory data to

demonstrate that there is reduced

bacterial contamination on poultry

processed with hydrogen peroxide and

sodium bicarbonate, to provide TBA (2-

thiobarbituric acid, a representative

measure of lipid oxidation) values in

skin/fat and meat from processed

poultry, and to provide the basis to

estimate the amount of hydrogen

peroxide that reacts with poultry during

the proposed treatment. FDA requested

this information to: (1) Determine the

bacteriocidal effectiveness of the

petitioned use of the additive, (2) assess

the degree of oxidation of poultry lipids

by hydrogen peroxide, and (3) estimate

the human dietary exposure to

oxidation products that might be formed

in the chicken during processing and

might remain until consumption. The

petitioner failed to submit this

information that the agency had

requested in several letters. Without this

information the agency is not able to

determine the microbiological efficacy

and safety of treating fresh poultry with

a mixture of hydrogen peroxide and

sodium bicarbonate. This information is

essential for the agency to determine

whether the proposed use of this food

additive is safe, and whether it will

achieve its intended technical effect.

FDA has several safety concerns

regarding the petitioned use of the

mixture of hydrogen peroxide and

sodium bicarbonate that would be

addressed by the data and information

that FDA requested from the petitioner.

One concern is that this mixture may

not kill significant numbers of the

pathogenic microbes on the surface of

the chicken skin. Thus, human exposure

to these pathogens could be higher with

the use of the mixture of hydrogen

peroxide and sodium bicarbonate than

human exposure to these pathogens

from currently used methods for killing

bacteria on the surface of chicken skin,

for example processing poultry in

chlorinated water. In addition, it is

possible that the mixture of hydrogen

peroxide and sodium bicarbonate will

kill off nonpathogenic microbes, giving

a competitive advantage to the

pathogens, so that they may reproduce

to higher numbers. Another safety

concern is that hydrogen peroxide is a

strong oxidant that could interact with

lipids and other biological constituents

in the skin of chicken to form oxidation

products. These oxidation products

could potentially be mutagenic and

represent a hazard to consumers.

Thus, on March 9, 1992, because the

petitioner failed to correct the

deficiencies in the petition as

previously described, FDA notified the

petitioner that it would not continue to

evaluate this submitted petition (Ref. 4).

Although the petitioner continued to

correspond with the agency, at no time

did he submit the requested

information. In a September 18, 1995,

letter to FDA the petitioner asked

whether he had exhausted his

administrative remedies. Before

receiving a response from FDA, on

December 6, 1995, the petitioner filed,

in the U.S. District Court for the

Northern District of Georgia, Gainesville

Division, a pro se complaint against

FDA and others alleging patent and

copyright infringement, antitrust

violations, Racketeer Influenced and

Corrupt Organizations Act violations,

fraud, and various torts. The Court

dismissed the complaints without

prejudice on March 20, 1996.

In a letter dated October 16, 1996, the

agency responded to the petitioner’s

earlier question on whether the

petitioner had exhausted his

administrative remedies. In that letter,

the agency stated that the petitioner had

not exhausted his administrative

remedies, and that he could either file

a new petition that would include the

supplemental information requested by

the agency or send a written request to

FDA asking the agency to file the

petition as submitted in accordance

with § 171.1(i)(1). The petitioner

responded in a November 4, 1996, letter

indicating that he wanted FDA to

approve the proposed use of the

additive and did not intend to

supplement the petition. Therefore, on

December 10, 1996, FDA filed the

petition as submitted in accordance

with § 171.1(i)(1) (62 FR 101, January 2,

1997).

The filed petition (FAP 7A4530)

proposed that the food additive

regulations be amended to provide for

the safe use of a mixture of hydrogen

peroxide and sodium bicarbonate as an

antimicrobial agent on fresh poultry.

After reviewing the petition, which the

petitioner did not supplement in order

to correct previously identified

deficiencies, the agency concluded that

the petition does not contain data and

information that would allow the

agency to conclude that the food

additive is safe and that it will achieve

its intended technical effect. Therefore,

FDA is denying FAP 7A4530 in

accordance with 21 CFR 171.100(a).

References

The following information has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Letter dated January 6, 1988, from FDA

to the petitioner.

2. Letter dated April 14, 1988, from FDA

to the petitioner.

3. Letter dated June 15, 1989, from FDA to

the petitioner.

4. Letter dated March 9, 1992, from FDA

to the petitioner.

Any person who will be adversely

affected by the foregoing order may at

any time on or before October 27, 1997,

file with the Dockets Management

Branch (address above) written

objections thereto. Each objection shall

be separately numbered. Each numbered

objection shall show wherein the person

filing will be adversely affected by the

order, specify with particularity the

provisions of the order to which

objection is made, and state the grounds

for the objection. Each numbered

objection on which a hearing is

requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include
Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Notices 50619

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the order may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: September 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25588 Filed 9–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0398]

Guidance for Industry on Extended

Release Oral Dosage Forms:

Development, Evaluation, and

Application of In Vitro/In Vivo

Correlations; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document for

industry entitled ‘‘Extended Release

Oral Dosage Forms: Development,

Evaluation, and Application of In Vitro/

In Vivo Correlations.’’ This guidance

document is intended to provide

recommendations to pharmaceutical

sponsors who intend to develop

documentation in support of an in vitro/

in vivo correlation (IVIVC) for an oral

extended release (ER) drug product for

submission in a new drug application

(NDA), abbreviated new drug

application (ANDA), or antibiotic drug

application (ANDA/AADA).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Extended Release Oral

Dosage Forms: Development,

Evaluation, and Application of In Vitro/

In Vivo Correlations’’ 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

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Ramana Uppoor, Center for Drug

Evaluation and Research, HFD–860,

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5305.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance document for industry entitled

‘‘Extended Release Oral Dosage Forms:

Development, Evaluation, and

Application of In Vitro/In Vivo

Correlations.’’ This guidance document

provides recommendations to

pharmaceutical sponsors who intend to

develop documentation in support of an

IVIVC for an oral ER drug product for

submission in an NDA, ANDA, or

AADA. The guidance presents a

comprehensive perspective on: (1)

Methods of developing an IVIVC and

evaluating its predictability; (2) using an

IVIVC to set dissolution specifications;

and (3) applying an IVIVC as a surrogate

for in vivo bioequivalence when it is

necessary to document bioequivalence

during the initial approval process or

because of certain preapproval or

postapproval changes, e.g., formulation,

equipment, process, and manufacturing

site changes.

This guidance document represents

the agency’s current thinking on the

development, evaluation, and

application of in vitro/in vivo

correlations for an oral ER drug product

for submission in an NDA, ANDA, or

AADA. 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, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). 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 guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

An electronic version of this guidance

is also available on the Internet at http:/

/www.fda.gov/cder/guidance/

index.htm.

Dated: September 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25514 Filed 9–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4235–N–22]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: September 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1226; TDD

number for the hearing- and speechimpaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: September 18, 1997.

Fred Karnas, Jr.,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 97–25183 Filed 9–25–97; 8:45 am]

BILLING CODE 4210–29–M