Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 56491 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

■ 2. Section 314.3 is amended in 

paragraph (b) by adding the following 

definition for authorized generic drug in 

alphabetical order: 

§ 314.3 Definitions. 

* * * * * 

(b) * * * 

Authorized generic drug means a 

listed drug, as defined in this section, 

that has been approved under section 

505(c) of the act and is marketed, sold, 

or distributed directly or indirectly to 

retail class of trade with labeling, 

packaging (other than repackaging as the 

listed drug in blister packs, unit doses, 

or similar packaging for use in 

institutions), product code, labeler code, 

trade name, or trade mark that differs 

from that of the listed drug. 

* * * * * 

■ 3. Section 314.81 is amended by 

redesignating paragraph (b)(2)(ii) as 

paragraph (b)(2)(ii)(a) and by adding 

new paragraph (b)(2)(ii)(b) as follows: 

§ 314.81 Other postmarketing reports. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(b) Authorized generic drugs. If 

applicable, the date each authorized 

generic drug (as defined in § 314.3) 

entered the market, the date each 

authorized generic drug ceased being 

distributed, and the corresponding trade 

or brand name. Each dosage form and/ 

or strength is a different authorized 

generic drug and should be listed 

separately. The first annual report 

submitted on or after February 11, 2009, 

must include the information listed in 

this paragraph for any authorized 

generic drug that was marketed during 

the time period covered by an annual 

report submitted after January 1, 1999. 

If information is included in the annual 

report with respect to any authorized 

generic drug, a copy of that portion of 

the annual report must be sent to the 

Food and Drug Administration, Center 

for Drug Evaluation and Research, 

Office of Pharmaceutical Science, 10903 

New Hampshire Ave., Bldg. 51, rm. 

4183, Silver Spring, MD 20993–0002 

and marked ‘‘Authorized Generic 

Submission’’ or, if FDA has required 

that annual reports be submitted in an 

electronic format, the information 

required by this section must also be 

submitted in the electronic format. 

* * * * * 

Dated: September 16, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22833 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

OCCUPATIONAL SAFETY AND 

HEALTH REVIEW COMMISSION 

29 CFR Parts 2200 and 2203 

Rules of Procedure; Regulations 

Implementing the Government in the 

Sunshine Act; Corrections and 

Technical Amendments 

AGENCY: Occupational Safety and Health 

Review Commission. 

ACTION: Final rule; corrections and 

technical amendments. 

SUMMARY: The Occupational Safety and 

Health Review Commission (OSHRC) is 

making corrections and technical 

amendments to its rules and regulations, 

which include revisions to its address 

and regularly scheduled meeting time, 

as well as corrections of erroneous 

cross-references and a typographical 

error. 

DATES: Effective on September 29, 2008. 

FOR FURTHER INFORMATION CONTACT: Ron 

Bailey, Attorney-Advisor, Office of the 

General Counsel, by telephone at (202) 

606–5410, by e-mail at 

rbailey@oshrc.gov, or by mail at: 1120— 

20th Street, NW., Ninth Floor, 

Washington, DC 20036–3457. 

SUPPLEMENTARY INFORMATION: 

I. Background 

OSHRC is making several corrections 

and technical amendments to its Rules 

of Procedure found at 29 CFR part 2200, 

and its Regulations Implementing the 

Government in Sunshine Act found at 

29 CFR part 2203. 

As to 29 CFR part 2200, OSHRC is 

correcting a typographical error in 

§ 2200.63(b) by removing ‘‘zequesten¢’’ 

and adding in its place ‘‘requested.’’ 

Also, in §§ 2200.57(a) and 2200.96, 

OSHRC is amending the reference to its 

nine-digit ZIP code, which has been 

changed from 20036–3419 to 20036– 

3457. Finally, OSHRC is correcting 

cross-references that should have been 

amended when OSHRC revised its Rules 

of Procedure on July 3, 1997 (62 FR 

35961). In that revision, OSHRC 

reduced the period specified in 

§ 2200.90(b)(2) for transmitting a judge’s 

decision to the Executive Secretary from 

20 days to 10 days. This 20-day period 

was previously cross-referenced in 

§§ 2200.91(c) and 2200.209(g), but was 

inadvertently left unchanged. Therefore, 

§ 2200.91(c), which refers to ‘‘the 20 

days provided by § 2200.90(b),’’ is 

corrected to read ‘‘the 10 days provided 

by § 2200.90(b)’’; and § 2200.209(g), 

which refers to the ‘‘21 day period 

provided for in rule § 2200.90(b)(2),’’ is 

corrected to read the ‘‘11-day period 

provided for in rule § 2200.90(b)(2).’’ 

As to 29 CFR part 2203, OSHRC is 

amending the time of its regularlyscheduled meetings. Sections 2203.2 

(definition of ‘‘Regularly-scheduled 

meetings’’) and 2203.4(c) presently state 

that such meetings are held at 10 a.m. 

every Thursday, except for legal 

holidays. In both sections, this meeting 

time is being amended to ‘‘10:30 a.m.’’ 

every Thursday, except for legal 

holidays. Also, in §§ 2203.4(c) and 

2203.7(b), OSHRC is amending the 

reference to its nine-digit ZIP code from 

20036–3419 to 20036–3457. 

II. Statutory and Executive Order 

Reviews 

Waiver of Proposed Rulemaking: For 

good cause, OSHRC finds that prior 

notice and opportunity for comment on 

these changes are unnecessary pursuant 

to 5 U.S.C. 553(b)(3)(B), because the 

amendments and corrections to the 

affected sections are merely technical in 

nature and propose no substantive 

changes on which public comment 

could be solicited. 

Waiver of 30-Day Delayed Effective 

Date Requirement: OSHRC finds that 

good cause exists for the final rule to be 

exempt from the 30-day delayed 

effective date requirement of 5 U.S.C. 

553(d) because a delay in clarifying 

these rules would be contrary to the 

public interest. 

Executive Orders 12866 and 13132, 

and the Unfunded Mandates Reform 

Act of 1995: OSHRC is an independent 

regulatory agency, and, as such, is not 

subject to the requirements of E.O. 

12866, E.O. 13132, or the Unfunded 

Mandates Reform Act, 2 U.S.C. 1501 et 

seq. 

Regulatory Flexibility Act: OSHRC has 

determined that this rulemaking is 

exempt from the requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 

604(a), because, as noted, a general 

notice of proposed rulemaking is not 

required under 5 U.S.C. 553(b). 

Paperwork Reduction Act of 1995: 

OSHRC has determined that the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., is not applicable here 

because this final rule contains no 

information collection requirements that 

require the approval of OMB. 

Congressional Notification: OSHRC 

has determined that the Congressional 

Review Act, 5 U.S.C. 801, is not 


jlentini on PROD1PC65 with RULES
56492 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Rules and Regulations 

applicable here because, pursuant to 5 

U.S.C. 804(3)(C), this final rule ‘‘does 

not substantially affect the rights or 

obligations of non-agency parties.’’ 

List of Subjects 

29 CFR Part 2200 

Administrative practice and 

procedure. 

29 CFR Part 2203 

Sunshine Act. 

Signed at Washington, DC, on the 23rd day 

of September, 2008. 

Horace A. Thompson III, 

Chairman. 

Thomasina V. Rogers, 

Commissioner. 

■ Accordingly, 29 CFR parts 2200 and 

2203 are corrected by making the 

following amendments: 

PART 2200—RULES OF PROCEDURE 

■ 1. The authority citation for part 2200 

continues to read as follows: 

Authority: 29 U.S.C. 661(g), unless 

otherwise noted. Section 2200.96 is also 

issued under 28 U.S.C. 2112(a). 

■ 2. In § 2200.57, paragraph (a), in the 

third sentence, remove the ZIP code 

suffix ‘‘3419’’ and add, in its place, 

‘‘3457’’. 

■ 3. In § 2200.63, paragraph (b), correct 

‘‘zequesten¢’’ to read ‘‘requested’’. 

■ 4. In § 2200.91, paragraph (c), in the 

fourth sentence, remove the number 

‘‘20’’ and add, in its place, ‘‘10’’. 

■ 5. In § 2200.96, in the first sentence, 

remove the ZIP code suffix ‘‘3419’’ and 

add, in its place, ‘‘3457’’. 

■ 6. In § 2200.209, paragraph (g), in the 

last sentence, remove the phrase ‘‘21 

day’’ and add, in its place, ‘‘11-day’’. 

PART 2203—REGULATIONS 

IMPLEMENTING THE GOVERNMENT IN 

THE SUNSHINE ACT 

■ 7. The authority citation for part 2203 

continues to read as follows: 

Authority: 29 U.S.C. 661(g); 5 U.S.C. 

552b(d)(4); 5 U.S.C. 552b(g). 

■ 8. In § 2203.2, in the definition of 

‘‘Regularly-scheduled meetings,’’ 

remove the time ‘‘10:00 a.m.’’ and add, 

in its place, ‘‘10:30 a.m.’’ 

■ 9. In § 2203.4, paragraph (c), in the 

first sentence, remove the time ‘‘10:00 

a.m.’’ and add, in its place, ‘‘10:30 a.m.’’ 

■ 10. In § 2203.4, paragraph (c), in the 

first sentence, remove the ZIP code 

suffix ‘‘3419’’ and add, in its place, 

‘‘3457’’. 

■ 11. In § 2203.7, paragraph (b), in the 

third sentence, remove the ZIP code 

suffix ‘‘3419’’ and add, in its place, 

‘‘3457’’. 

[FR Doc. E8–22783 Filed 9–26–08; 8:45 am] 

BILLING CODE 7600–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 151 

[Docket No. USCG–2004–19621] 

RIN 1625–AA89 

Dry Cargo Residue Discharges in the 

Great Lakes 

AGENCY: Coast Guard, DHS 

ACTION: Interim rule; request for 

comments. 

SUMMARY: The Coast Guard is amending 

its regulations to allow the discharge of 

bulk dry cargo residue (DCR) in limited 

areas of the Great Lakes by selfpropelled vessels and by any barge that 

is part of an integrated tug and barge 

unit. DCR is the residue of non-toxic 

and non-hazardous bulk dry cargo like 

limestone, iron ore, and coal. These 

regulations also add new recordkeeping 

and reporting requirements and 

encourage carriers to adopt voluntary 

control measures for reducing 

discharges. Discharges are now 

prohibited in certain protected and 

sensitive areas where, previously, they 

were allowed. The Coast Guard also 

requests public comments on the need 

for and feasibility of additional 

conditions that might be imposed on 

discharges in the future, such as 

mandatory use of control measures, or 

further adjustments to the areas where 

discharges are allowed or prohibited. 

DATES: This interim rule takes effect 

September 29, 2008. Initial reports 

under amended 33 CFR 151.66(c)(4) are 

due January 15, 2009. Comments and 

related material submitted in response 

to the request for comments must reach 

the Docket Management Facility on or 

before January 15, 2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2004–19621 and are 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet at 

http://www.regulations.gov. 

We encourage you to submit 

comments identified by Coast Guard 

docket number USCG–2004–19621 to 

the Docket Management Facility at the 

U.S. Department of Transportation. To 

avoid duplication, please use only one 

of the following methods: 

(1) Online: http:// 

www.regulations.gov. 

(2) Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. 

(3) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

(4) Fax: 202–493–2251. 

Anyone can search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act system of records notice regarding 

our public dockets in the January 17, 

2008 issue of the Federal Register (73 

FR 3316). 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this interim rule, 

call LT Heather St. Pierre, U.S. Coast 

Guard, telephone 202–372–1432 or email Heather.J.St.Pierre@uscg.mil. If you 

have questions on viewing or submitting 

material to the docket, call Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Acronyms 

II. Regulatory History and Good Cause for 

Immediate Effectiveness 

III. Background, Purpose, and Discussion of 

Rule 

IV. Discussion of Comments 

V. Request for Additional Comments 

VI. Regulatory Evaluation 

A. Executive Order 12866 

B. Small Entities 

C. Assistance for Small Business 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates Reform Act 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Acronyms 

APA Administrative Procedure Act 

DCR Dry Cargo Residue 


jlentini on PROD1PC65 with RULES