49648 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Proposed Rules

criteria and to be suitable for

distribution.

3. Section 600.14 is amended by

revising the section heading and

paragraph (a) and by adding new

paragraph (c) to read as follows:

§ 600.14 Reporting of errors and

accidents.

(a) Except as provided in paragraph

(c) of this section, the Director, Office of

Compliance (HFM–650), Center for

Biologics Evaluation and Research, 1401

Rockville Pike, Rockville, MD 20852–

1448, shall be notified as soon as

possible but not to exceed 45 calendar

days, of errors or accidents in the

manufacture of products that may affect

the safety, purity, or potency of any

biological product made available for

distribution.

* * * * *

(c) In lieu of the requirements of

paragraph (a) of this section, all

manufacturers of blood and blood

components shall submit reports to FDA

in accordance with § 606.171 of this

chapter.

PART 606—CURRENT GOOD

MANUFACTURING PRACTICE FOR

BLOOD AND BLOOD COMPONENTS

4. The authority citation for 21 CFR

part 606 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 505,

510, 520, 701, 704 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 355, 360, 360j, 371, 374); secs. 215, 351,

353, 361 of the Public Health Service Act (42

U.S.C. 216, 262, 263a, 264).

5. Section 606.3 is amended by

adding new paragraphs (k) and (l) to

read as follows:

§ 606.3 Definitions.

* * * * *

(k) Error and accident means:

(1) An event that represents a

deviation from current good

manufacturing practice (CGMP),

applicable standards, or established

specifications that may affect the safety,

purity, or potency of blood or blood

components, including source plasma,

or otherwise cause the product to be in

violation of the Federal Food, Drug, and

Cosmetic Act or the Public Health

Service Act, or

(2) An unexpected or unforeseeable

event that may affect the safety, purity,

or potency of blood or blood

components, including source plasma,

or otherwise cause the product to be in

violation of the Federal Food, Drug, and

Cosmetic Act or the Public Health

Service Act.

(l) Made available for distribution

means that the blood or blood

component, including source plasma,

has been determined to meet all release

criteria and to be suitable for

distribution.

6. Section 606.171 is added to subpart

I to read as follows:

§ 606.171 Error and accident reporting,

blood and blood components.

All establishments as defined in

§ 607.3(c) of this chapter shall notify the

Director, Office of Compliance (HFM–

600), Center for Biologics Evaluation

and Research, 1401 Rockville Pike,

Rockville, MD 20852–1448, as soon as

possible but not to exceed 45 calendar

days, of errors or accidents in the

manufacture of blood or blood

components, including source plasma,

that may affect the safety, purity, or

potency of any blood or blood

component made available for

distribution.

Dated: June 25, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–25129 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[ME–046–6996b; A–1–FRL–5894–7]

Approval and Promulgation of Air

Quality Implementation Plans; Maine;

(General Conformity Rule)

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve

a State Implementation Plan (SIP)

revision submitted by the State of Maine

for the purpose of implementing

General Conformity (Section

176(c)(4)(C) of the Clean Air Act (CAA)

and its regulations 40 CFR part 51,

Subpart W). The Maine SIP incorporates

by reference the criteria and procedures

set forth at 40 CFR part 51, Subpart W.

This SIP revision establishes and

requires federal actions to conform to all

applicable implementation plans

developed pursuant to Section 110 and

Part D of the CAA. In the Final Rules

Section of this Federal Register, EPA is

approving the State’s SIP revision as a

direct final rule without prior proposal

because the Agency views this as a

noncontroversial revision amendment

and anticipates no adverse comments. A

detailed rationale for the approval is set

forth in the direct final rule. If no

adverse comments are received in

response to that direct final rule, no

further activity is contemplated in

relation to this proposed rule. If EPA

receives adverse comments, the direct

final rule will be withdrawn and all

public comments received will be

addressed in a subsequent final rule

based on this proposed rule. EPA will

not institute a second comment period

on this proposal. Any parties interested

in commenting on this proposal should

do so at this time.

DATES: Comments must be received on

or before October 23, 1997.

ADDRESSES: Comments may be mailed to

Susan Studlien, Deputy Director, Office

of Ecosystem Protection (mail code

CAA), U.S. Environmental Protection

Agency, Region I, JFK Federal Bldg.,

Boston, MA 02203. Copies of the State

submittal are available for public

inspection during normal business

hours, by appointment at the Office of

Ecosystem Protection, U.S.

Environmental Protection Agency,

Region I, One Congress Street, 11th

floor, Boston, MA and the Bureau of Air

Quality Control, Department of

Environmental Protection, 71 Hospital

Street, Augusta, ME 04333.

FOR FURTHER INFORMATION CONTACT:

Donald O. Cooke, (617) 565–3508, at the

EPA Region I address above.

SUPPLEMENTARY INFORMATION: For

additional information, see the direct

final rule which is located in the Rules

Section of this Federal Register.

Authority: 42 U.S.C. 7401—7671q.

Dated: September 9, 1997.

John P. DeVillars,

Regional Administrator, Region I.

[FR Doc. 97–25229 Filed 9–22–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[PA58–4039; AD–FRL–5897–2]

Approval and Promulgation of Air

Quality Implementation Plans;

Pennsylvania; Pennsylvania Power—

New Castle NOX RACT Proposal;

Extension of Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule; extension of the

comment period.

SUMMARY: EPA is reopening the

comment period for a proposed rule

published on August 18, 1997 (62 FR

43959). In the August 18 document,

EPA proposed to disapprove the April

19, 1995 Pennsylvania Department of
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Proposed Rules 49649

Environmental Protection proposal for

nitrogen oxide reasonably available

control technology (NOX RACT) for the

Pennsylvania Power—New Castle plant

located in Lawrence County. At the

request of Paul, Hastings, Janofsky &

Walker LLP, attorneys representing

Pennsylvania Power—New Castle plant,

EPA is extending the comment period

through November 18, 1997.

DATES: Comments must be received on

or before November 18, 1997.

ADDRESSES: Comments may be mailed to

David L. Arnold, Chief, Ozone/CO and

Mobile Sources Section, Mailcode

3AT21, U.S. Environmental Protection

Agency, Region III, 841 Chestnut

Building, Philadelphia, Pennsylvania

19107.

FOR FURTHER INFORMATION CONTACT:

Cynthia H. Stahl, U.S. EPA Region III,

(215) 566–2180.

Dated: September 16, 1997.

W. Michael McCabe,

Regional Administrator, Region III.

[FR Doc. 97–25224 Filed 9–22–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[Region 2 Docket No. NY24–2–172a; FRL–

5892–4]

Approval and Promulgation of

Implementation Plans; Reasonably

Available Control Technology for

Oxides of Nitrogenfor Specific Sources

in the State of New York

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The EPA proposes to approve

three (3) State Implementation Plan

(SIP) revisions submitted by the State of

New York related to development of

reasonably available control

technologies for oxides of nitrogen from

various sources in the State. In the Final

Rules section of this Federal Register,

EPA is approving the State’s SIP

revisions, as a direct final rule without

prior proposal because the Agency

views this as a noncontroversial

revision and anticipates no adverse

comments. A detailed rationale for the

approval is set forth in the direct final

rule. If no adverse comments are

received in response to that direct final

rule no further activity is contemplated

in relation to this proposed rule. If EPA

receives adverse comments, the direct

final rule will be withdrawn and all

public comments received will be

addressed in a subsequent final rule

based on this proposed rule. The EPA

will not institute a secondcomment

period on this rulemaking. Any parties

interested in commenting on this

Federal Register should do so at this

time.

DATES: Comments must be received on

or before October 23, 1997.

ADDRESSES: All comments should be

addressed to: Ronald Borsellino, Chief,

Air Programs Branch, Environmental

Protection Agency, Region 2 Office, 290

Broadway, New York, New York 10007–

1866.

Copies of the State submittal are

available at the following addresses for

inspection during normal business

hours:

Environmental Protection Agency,

Region 2 Office, 290 Broadway, 25th

Floor, New York, New York 10007–

1866.

New York Department of

Environmental Conservation, Division

of Air Resources, 50 Wolf Road, Albany,

New York 12233.

FOR FURTHER INFORMATION CONTACT: Ted

Gardella or Rick Ruvo, Air Programs

Branch, Environmental Protection

Agency, 290 Broadway, 25th Floor, New

York, New York 10007–1866, (212) 637–

4249.

SUPPLEMENTARY INFORMATION: For

additional information see the direct

final rule which is published in the

rules section of this Federal Register.

Dated: September 2, 1997.

William J. Muszynski,

Acting Regional Administrator.

[FR Doc. 97–25231 Filed 9–22–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 86

[FRL–5897–5]

Control of Air Pollution From New

Motor Vehicles and New Motor Vehicle

Engines; Voluntary Standards for

Light-Duty Vehicles; Extension of

Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule; extension of

comment period.

SUMMARY: The U.S. Environmental

Protection Agency is extending the

comment period on the Supplemental

Notice of Proposed Rulemaking

(SNPRM) which takes comment on the

few remaining issues necessary to

finalize the regulations for the National

LEV program, and which appeared in

the Federal Register on August 22, 1997

(62 FR 44754). The public comment

period was to end on September 22,

1997. The purpose of this document is

to extend the comment period an

additional 7 days beyond that, to end on

September 29, 1997. This extension of

the comment period is provided to

allow commenters additional time to

respond to the SNPRM.

DATES: EPA will accept public

comments on the Supplemental Notice

of Proposed Rulemaking until

September 29, 1997.

ADDRESSES: Written comments should

be submitted (in duplicate if possible)

to: the EPA, Air Docket, Room M–1500

(Mail Code 6102), Waterside Mall, Attn:

Docket A–95–26, 401 M Street, SW.,

Washington, DC 20460. Materials

relevant to this rulemaking are

contained in Docket No. A–95–26. The

docket is located at The Air Docket, 401

M Street, SW., Washington, DC 20460,

and may be viewed in room M–1500

between 8:00 a.m. and 5:30 p.m.,

Monday through Friday. The telephone

number is (202) 260–7548 and the

facsimile number is (202) 260–4400. A

reasonable fee may be charged by EPA

for copying docket material.

FOR FURTHER INFORMATION CONTACT: Karl

Simon, Office of Mobile Sources, U.S.

Environmental Protection Agency, 401

M Street SW, Washington, DC 20460.

Telephone (202) 260–3623; Fax (202)

260–6011; e-mail

simon.karl@epamail.epa.gov.

Dated: September 17, 1997.

Richard D. Wilson,

Acting Assistant Administrator for Air and

Radiation.

[FR Doc. 97–25233 Filed 9–22–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Chapter IV

[OMC–029–N]

RIN 0938–AI25

Medicare Program; Solvency

Standards for Provider-Sponsored

Organizations; Intent To Form

Negotiated Rulemaking Committee

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Intent to form negotiated

rulemaking committee and notice of

meetings.