Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Proposed Rules 26473

agency and application coordination

responsibilities under the Act if such an

application were filed using fiscal

agency procedures already in place in

other contexts and on a case-by-case

basis.

Initial Regulatory Flexibility Analysis

The Regulatory Flexibility Act (5

U.S.C. 601 et seq.) requires an agency to

publish an initial regulatory flexibility

analysis with any notice of proposed

rulemaking. Two of the requirements of

an initial regulatory flexibility analysis

(5 U.S.C. 603(b) (1)–(2)), a description of

the reasons why action by the agency is

being considered and a statement of the

objectives of, and legal basis for, the

proposal, are contained in the

supplementary material above. The

proposal rule imposes no additional

reporting or recordkeeping requirements

and does not overlap with other federal

rules. (5 U.S.C. 603(b) (4)–(5).)

Another requirement for the initial

regulatory flexibility analysis is a

description of and, where feasible, an

estimate of the number of small entities

to which the proposed rule will apply.

(5 U.S.C. 603(b)(3).) The proposal will

apply to all depository institutions

regardless of size. The proposal seeks to

eliminate an obsolete regulatory

provision and does not impose any

substantial economic burden on small

entities.

By order of the Board of Governors of the

Federal Reserve System, May 21, 1996.

William W. Wiles,

Secretary of the Board.

[FR Doc. 96–13225 Filed 5–24–96; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–AGL–1]

Proposed Amendment of Class E

Airspace; Rochester, MN

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking;

withdrawal.

SUMMARY: This action withdraws the

Notice of Proposed Rulemaking (NPRM)

which amended the Class E airspace at

Rochester, MN. The airspace, as

published, was incomplete and will be

reissued subsequently with the

corrected airspace description.

DATES: May 28, 1996.

FOR FURTHER INFORMATION CONTACT:

John A. Clayborn, Air Traffic Division,

Operations Branch, AGL–530, Federal

Aviation Administration, 2300 East

Devon Avenue, Des Plaines, Illinois

60018, telephone (847) 294–7459.

SUPPLEMENTARY INFORMATION:

The Proposed Rule

On March 22, 1996, a Notice of

Proposed Rulemaking was published in

the Federal Register to amend the Class

E airspace at Rochester, MN. This was

necessary to accommodate the new

Copter GPS 325 degrees approach

procedure to St. Mary’s Hospital

Heliport, Rochester, MN (61 FR 11792).

The airspace description, as published,

was incomplete; therefore this NPRM is

being withdrawn and will be reissued.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Withdrawal of Proposed Rule

Accordingly, pursuant to the

authority delegated to me, Airspace

Docket No. 96–AGL–1, as published in

the Federal Register on March 22, 1996

(61 FR 11792), is hereby withdrawn.

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 49 U.S.C. 14 CFR 11.69.

Issued in Des Plaines, Illinois on May 1,

1996.

Maureen Woods,

Acting Manager, Air Traffic Division.

[FR Doc. 96–13254 Filed 5–24–96; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 96N–0002]

‘‘Draft Document Concerning the

Regulation of Placental/Umbilical Cord

Blood Stem Cell Products Intended for

Transplantation or Further

Manufacture into Injectable Products;’’

Availability; Extension of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Availability of draft document;

extension of comment period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

July 26, 1996, the comment period for

the draft document entitled ‘‘Draft

Document Concerning the Regulation of

Placental/Umbilical Cord Blood Stem

Cell Products Intended for

Transplantation or Further Manufacture

into Injectable Products,’’ which

appeared in the Federal Register of

February 26, 1996 (61 FR 7087). The

purpose of the draft document is to

identify a draft regulatory approach that

FDA believes is appropriate for the

regulation of placental/umbilical cord

blood stem cell products for

transplantation. FDA published the

draft document in response to numerous

inquiries regarding the agency’s

regulatory approach to cord blood stem

cell products and to provide an

opportunity for interested persons to

submit written comments on the draft

document prior to fully implementing

this approach. FDA is taking this action

in response to requests to allow

additional time for public comments.

DATES: Written comments by July 26,

1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 26, 1996

(61 FR 7087), FDA requested public

comment from interested persons on the

draft document which included

discussions of the following: (1) The

applicable legal authorities in the

Federal Food, Drug, and Cosmetic Act

and the Public Health Service Act; (2)

FDA’s approach to the regulation of

human cord blood stem cells intended

for transplantation; (3) FDA’s approach

to the regulation of cord blood stem

cells as source material for further

manufacture; and (4) FDA’s approach to

the regulation of ancillary products used

for production of cord blood stem cells.

Interested persons were given until

April 26, 1996, to submit written

comments on the draft document.

The agency received four letters from

companies and research institutions

involved in the collection and storage of

cord blood requesting an extension of

the comment period. The letters

requested up to 90 additional days for

comment on the basis that FDA’s

proposed regulatory approach would

significantly alter the current cord blood

collection and storage practices used by

companies and research institutions. In

addition, the requests cited the need for

additional time to adequately review