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Federal Register / Vol. 64, No.

222 / Thursday, November 18, 1999 / Rules and Regulations 62977

(3) Earnings that will ordinarily show DEPARTMENT OF HEALTH AND Authority: 21 CFR U.S.C. 351, 360, 360c,
that the claimant has not engaged in HUMAN SERVICES 360e, 360j, 371.
substantial gainful activity. The Board 2. Section 884.6190 is amended by
will generally consider that the earnings Food and Drug Administration removing the last sentence in paragraph
from the employed claimant’s work will (a), and paragraph (b) is revised to read
21 CFR Part 884 as follows:
show that the claimant has not engaged
in substantial gainful activity if— [Docket No. 97N–0335] § 884.6190 Assisted reproductive
microsopes and microscope accessories.
Monthly Obstetric and Gynecologic Devices;
* * * * *
For months earnings Reclassification and Classification of
averaged (b) Classification. Class 1. This device
Medical Devices Used for In Vitro
less than is exempt from the premarket
Fertilization and Related Assisted
notification procedures in subpart E of
Reproduction Procedures; Technical
In calendar years before 1976 ... $130 part 807 of chapter subject to limitation
In calendar year 1976 ................ 150
Amendment
in § 884.9.
In calendar year 1977 ................ 160 AGENCY: Food and Drug Administration, Dated: November 4, 1999.
In calendar year 1978 ................ 170 HHS. Linda S. Kahan,
In calendar year 1979 ................ 180
Final rule; technical
ACTION: Deputy Director for Regulations Policy, Center
In calendar years 1980–1989 ..... 190
amendment. for Devices and Radiological Health.
After December 1989 ................. 300
[FR Doc. 99–30084 Filed 11–17–99; 8:45 am]
SUMMARY: The Food and Drug
BILLING CODE 4160–01–F
(4) If the claimant works in a Administration (FDA) is amending its
sheltered workshop. If the claimant is obstetrical and gynecological device
working in a sheltered workshop or a regulations regarding assisted
reproductive microscopes and LIBRARY OF CONGRESS
comparable facility especially set up for
severely impaired persons, the microscope accessories. This action is
Copyright Office
claimant’s earnings and activities will being taken to ensure accuracy and
ordinarily establish that the claimant clarity in the agency’s regulations. 37 CFR Part 202
has not done substantial gainful activity EFFECTIVE DATE: November 18, 1999.
[Docket No.: RM–99–6]
if— FOR FURTHER INFORMATION CONTACT:
LaJuana D. Caldwell, Office of Policy Copyright Rules and Regulations
Average (HF–27), Food and Drug
monthly Administration, 5600 Fishers Lane, AGENCY: Copyright Office, Library of
earnings Rockville, MD 20857, 301–827–7010. Congress.
For months are not
greater SUPPLEMENTARY INFORMATION: FDA has ACTION: Technical amendment.
than discovered that an error was
incorporated into the agency’s SUMMARY: The definition of what is the
In calendar years before 1976 ... $200 obstetrical and gynecological devices best edition of a published work is
In calendar year 1976 ................ 230 regulations for assisted reproductive found in 37 CFR 202.19(b)(1)(i). The
In calendar year 1977 ................ 240 microscopes and microscope Copyright Office is amending its
In calendar 1978 ......................... 260 accessories. In an amendment to 21 CFR regulations to clarify where the public
In calendar year 1979 ................ 280 part 884, which added 21 CFR 884.6190 may find a statement on the best edition
In calendar years 1980–1989 ..... 300 and published on September 10, 1998 of published copyrighted works for the
In January 1990–June 1999 ....... 500 (63 FR 48428), a sentence stating that collections of the Library of Congress.
After June 1999 .......................... 700 the device is exempt from the premarket The statement, which contains the
notification procedures was criteria for selection of what constitutes
* * * * * inadvertently included in paragraph (a) the ‘‘best edition’’ of a published work,
Dated: November 10, 1999. instead of paragraph (b). This document is located in appendix B of 37 CFR part
By authority of the Board. corrects that error. Publication of this 202.
For the Board. document constitutes final action under EFFECTIVE DATE: November 18, 1999.

Beatrice Ezerski,
the Administrative Procedure Act (5 FOR FURTHER INFORMATION CONTACT:
U.S.C. 553). FDA has determined that David O. Carson, General Counsel, or
Secretary to the Board.
notice and public comment are Marilyn J. Kretsinger, Assistant General
[FR Doc. 99–30074 Filed 11–17–99; 8:45 am] unnecessary because this amendment is Counsel, Copyright GC/I&R, PO Box
BILLING CODE 7905–01–P nonsubstantive. 70400, Southwest Station, Washington,
List of Subjects in 21 CFR Part 884 DC 20024. Telephone: (202) 707–8380.
Fax: (202) 707–8366.
Medical devices. SUPPLEMENTARY INFORMATION: Section
Therefore, under the Federal Food, 407 of the copyright statute requires that
Drug, and Cosmetic Act and under the best edition of a published work
authority delegated to the Commissioner must be deposited with a copyright
of Food and Drugs, 21 CFR part 884 is registration application so that the
amended as follows: Library of Congress may consider
PART 884—OBSTETRICAL AND whether to select a work for its
GYNECOLOGICAL DEVICES collections or for other suitable
purposes. See 37 CFR 202.19. The
1. The authority citation for 21 CFR Copyright Office is now amending its
part 884 continues to read as follows: regulation concerning what constitutes
62978 Federal Register / Vol. 64, No. 222 / Thursday, November 18, 1999 / Rules and Regulations

the ‘‘best edition’’ of a published work Federal Emissions Guidelines (EG) What public review opportunities were
for registration purposes. This applicable to existing MWCs with the provided?
amendment merely clarifies that the capacity to combust more than 250 Tons IV. Review and Approval of the Indiana
MWC State Plan
criteria for selection of the ‘‘best Per Day (TPD) of Municipal Solid Waste Why is the Indiana MWC State Plan
edition’’ of published copies or (MSW). The State Plan applies to the approvable?
phonorecords is located in appendix B Indianapolis Resource Recovery Facility How does the approval of the State Plan
title 37 of the Code of Federal in Indianapolis, Indiana. This approval affect Federal Plan requirements?
Regulations. Information about ‘‘best means that EPA finds the State Plan V. EPA Rulemaking Action
edition’’ copies or phonorecords is also meets applicable Clean Air Act (Act) VI. Administrative Requirements
located in the Office’s Circular 7b. requirements for MWC State Plans. A. Executive Order 12866
Once effective, the approval makes the B. Executive Order 13132
List of Subjects in 37 CFR Part 202 C. Executive Order 13045
State Plan federally enforceable, and D. Executive Order 13084
Copyright, Registration of claims to Indiana’s MWC will not be subject to E. Regulatory Flexibility Act
copyright. the MWC Federal Plan. F. Unfunded Mandates
For the reasons stated above, 37 CFR G. Submission to Congress and the
DATES: This rule is effective on January Comptroller General
part 202 is amended as follows:
18, 2000, unless EPA receives adverse H. National Technology Transfer and
PART 202—REGISTRATION OF written comments by December 20, Advancement Act
CLAIMS TO COPYRIGHT 1999. If adverse written comment is I. Petitions for Judicial Review
received, EPA will publish a timely
1. The authority citation for part 202 I. What Is EPA Approving in This
withdrawal of the rule in the Federal
continues to read as follows: Action?
Register and inform the public that the
Authority: 17 U.S.C. 702. rule will not take effect. We are approving the September 30,
1999, Indiana State Plan which
§ 202.19 [Amended] ADDRESSES: Written comments should implements the requirements of sections
be sent to: J. Elmer Bortzer, Chief, 111(d) and 129 of the Act as applicable
2. Section 202.19 is amended by
Regulation Development Section, Air to MWCs. This approval, once effective,
adding at the end of paragraph (b)(1)(i)
Programs Branch (AR–18J), U.S. will make the Indiana MWC rule
a new sentence to read as follows:
Environmental Protection Agency, 77 included in the plan federally
* * * * * West Jackson Boulevard, Chicago, enforceable.
(b) * * * Illinois 60604. You can inspect copies of
(l) * * * the State Plan submittal at the following II. The MWC State Plan Requirement
(i) * * * The ‘‘best edition’’ address: U.S. Environmental Protection What Is an MWC State Plan?
requirement is described in detail at Agency, Region 5, Air and Radiation
Appendix B to this part. An MWC State Plan is a plan to
Division, 77 West Jackson Boulevard,
* * * * * control air pollutant emissions from
Chicago, Illinois 60604. (We recommend
3. Section 202.19(b)(1)(ii) is amended certain combustors burning municipal
you contact Mark J. Palermo,
by removing ‘‘Copies of the Best Edition solid waste. The plan also includes
Environmental Protection Specialist, at source and emission inventory
Statement are available upon request (312) 886-6082 before visiting the
made to the Copyright Acquisitions information.
Region 5 Office).
Division.’’ . Why Did Indiana Submit an MWC State
FOR FURTHER INFORMATION CONTACT:
Dated: November 10, 1999. Plan?
Mark J. Palermo, Environmental
Marybeth Peters, Protection Specialist, at (312) 886–6082. Sections 111(d) and 129 of the Act
Register of Copyrights. require States to submit State Plans to
SUPPLEMENTARY INFORMATION: control emissions from existing MWCs
[FR Doc. 99–29877 Filed 11–17–99; 8:45 am]
Throughout this document wherever in the State. The State Plan requirement
BILLING CODE 1410–30–P
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ are used, we mean was triggered when we published the
EPA. EG for MWCs on December 19, 1995 (60
ENVIRONMENTAL PROTECTION Table of Contents FR 65387). We codified the EG at 40
AGENCY CFR part 60, subpart Cb.
I. What is EPA approving in this action? Under section 129 of the Act, we are
II. The MWC State Plan Requirement required to promulgate EGs for several
40 CFR Part 62
What is an MWC State Plan? categories of existing solid waste
[IN94–1a; FRL–6476–9] Why did Indiana submit an MWC State incinerators. Section 129 provides that
Plan? the emission limitations in the EGs may
Approval of Municipal Waste What pollutants does the MWC State Plan not be less stringent than the average
Combustor State Plan for Designated reduce? emission limitations achieved by the
Facilities and Pollutants: Indiana What criteria must an MWC State Plan best performing 12 percent of units in
meet to be approved?
AGENCY: Environmental Protection the category. This is commonly referred
III. The Indiana MWC Plan
Agency (EPA). to as the ‘‘Maximum Available Control
Who is affected by the Indiana MWC State
ACTION: Direct final rule. Plan?
Technology (MACT) floor’’ for existing
Where are the Indiana MWC requirements units. Emission control options less
SUMMARY: EPA is approving Indiana’s codified? stringent than the MACT floor can not
State Plan to control air pollutants from What does the Indiana MWC State Plan be considered in developing section 129
Municipal Waste Combustors (MWC). require? EGs. In addition to emission limitations,
The Indiana Department of When must the State Plan requirements be the MWC EG also establishes
Environmental Management (IDEM) met? requirements for compliance dates,
submitted the State Plan on September What else does the Indiana MWC State monitoring, and operator training, as
30, 1999. The State Plan adopts the Plan include? required by section 129.