59934 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 

construction contained in RUS Bulletin 

1753F–150 (RUS Form 515a). 

The current outside plant 

specifications are used by borrowers to 

secure the services of a contractor for 

the construction of telecommunications 

facilities. Current specifications have 

become outdated due to the 

advancements in Fiber-to-the-Home 

construction as well as installation 

methods and materials. In order for 

borrowers and contractors to take 

advantage of these improved 

construction installation methods and 

materials, the current specifications 

have been revised. 

On Tuesday, June 8, 2010, RUS 

published a proposed rule in the 

Federal Register (Vol. 75, No 109, page 

32313), proposing to amend its 

regulations on Telecommunications 

Policies on Specifications, Acceptable 

Materials, and Standard Contract Forms, 

by revising RUS Bulletin 1753F–150, 

Specifications and Drawings for 

Construction of Direct Buried Plant 

(Form 515a). Interested parties were 

invited to submit comments on or before 

August 9, 2010. No comments were 

received. 

List of Subjects in 7 CFR Part 1755 

Incorporation by reference, Loan 

programs—communications, Reporting 

and recordkeeping requirements, Rural 

areas, Telephone. 

■ For reasons set out in the preamble, 

RUS proposes to amend chapter XVII of 

title 7 of the Code of Federal 

Regulations as follows: 

PART 1755—TELECOMMUNICATIONS 

POLICIES ON SPECIFICATIONS, 

ACCEPTABLE MATERIALS, AND 

STANDARD CONTRACT FORMS 

■ 1. The authority citation for part 1755 

continues to read as follow: 

Authority: 7 U.S.C. 901 et seq., 1921 et 

seq., 6941 et seq. 

■ 2. In § 1755.97, the table is amended 

by revising the issue date of RUS 

Bulletin 1753F–150 to read as follows: 

§ 1755.97 Incorporation by reference of 

telecommunications standards and 

specifications. 

* * * * * 

RUS Bulletin No. Specification No. Date last issued Title of standard or specification 

*******

1753F–150 ......................... Form 515a ......................... September 2010 ................ Specifications and Drawings for Construction of Direct 

Buried Plant. 

* * * * * * * 

* * * 

Dated: September 23, 2010. 

Jonathan Adelstein, 

Administrator, Rural Utilities Service. 

[FR Doc. 2010–24420 Filed 9–28–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2010–0911; Airspace 

Docket No. 10–ASO–32] 

Amendment to Class E Airspace; 

Smithfield, NC 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule, technical 

amendment. 

SUMMARY: This action amends Class E 

airspace at Johnston County Airport, 

Smithfield, NC, by correcting an 

omission of the geographic coordinates 

of the Area Navigation (RNAV) Global 

Positioning System (GPS) Special 

Standard Instrument Approach 

Procedure (SIAP) serving the Johnston 

Memorial Hospital to aid in the 

navigation of our National Airspace 

System. 

DATES: Effective 0901 UTC, January 13, 

2011. The Director of the Federal 

Register approves this incorporation by 

reference action under title 1, Code of 

Federal Regulations, part 51, subject to 

the annual revision of FAA Order 

7400.9 and publication of conforming 

amendments. 

FOR FURTHER INFORMATION CONTACT: 

Melinda Giddens, Operations Support 

Group, Eastern Service Center, Federal 

Aviation Administration, P.O. Box 

20636, Atlanta, Georgia 30320; 

telephone (404) 305–5610. 

SUPPLEMENTARY INFORMATION: 

History 

The FAA received a request from the 

National Aeronautical Navigation 

Services to correct the omission of the 

geographic coordinates for the point in 

space serving Johnston Memorial 

Hospital in the amendment of the Class 

E airspace published in the Federal 

Register on July 27, 2010 (75 FR 43817). 

This action makes the adjustment. 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

amends Class E airspace at Smithfield, 

NC, by making the addition of the 

geographic coordinates of the RNAV 

(GPS) approach point in space serving 

Johnston Memorial Hospital to coincide 

with the FAAs National Aeronautical 

Navigation Services depiction. 

Accordingly, since this is an 

administrative change, and does not 

involve a change in the dimensions or 

operating requirements of that airspace, 

notice and public procedures under 5 

U.S.C. 553 (b) are unnecessary. 

The Class E airspace designations are 

published in Paragraph 6005 of FAA 

order 7400.9U, dated August 18, 2010, 

and effective September 15, 2010, which 

is incorporated by reference in 14 CFR 

71.1. The Class E airspace designations 

listed in this document will be 

published subsequently in the Order. 

The FAA has determined that his 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore, (1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a Regulatory 

Evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 


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Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Rules and Regulations 59935 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A. Subpart I, Section 

40103. Under that section, the FAA is 

charged with prescribing regulations to 

assign the use of airspace necessary to 

ensure the safety of aircraft and the 

efficient use of airspace. This regulation 

is within the scope of that authority as 

it amends controlled airspace at 

Smithfield, NC. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (Air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR Part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for Part 71 

continues to read as follows: 

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

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

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order 7400.9U, 

Airspace Designations and Reporting 

Points, dated August 18, 2010, and 

effective September 15, 2010, is 

amended as follows: 

Paragraph 6005 Class E Airspace Extending 

Upward From 700 feet or More Above the 

Surface of the Earth 

* * * * * 

ASO NC E5 Smithfield, NC [Amended] 

Johnston County Airport, NC 

(Lat. 35°32′27′′ N., long 78°23′25′′ W.) 

Johnston Memorial Hospital 

Point In Space Coordinates 

(Lat. 35°31′23′′ N., long 78°20′35′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of the Johnston County Airport and 

within 2 miles each side of the 023° bearing 

from the airport extending from the 6.5-mile 

radius to 10.2 miles northeast of the Johnston 

County Airport and within a 6-mile radius of 

the point in space (lat.35°31′23′′ N., long. 

78°20′35′′ W.) serving Johnston Memorial 

Hospital. 

Issued in College Park, Georgia, on 

September 17, 2010. 

Myron A. Jenkins, 

Acting Manager, Operations Support Group, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2010–24113 Filed 9–28–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 312 and 320 

[Docket No. FDA–2000–N–0108] (formerly 

Docket No. 00N–1484) 

RIN 0910–AG13 

Investigational New Drug Safety 

Reporting Requirements for Human 

Drug and Biological Products and 

Safety Reporting Requirements for 

Bioavailability and Bioequivalence 

Studies in Humans 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations governing safety reporting 

requirements for human drug and 

biological products subject to an 

investigational new drug application 

(IND). The final rule codifies the 

agency’s expectations for timely review, 

evaluation, and submission of relevant 

and useful safety information and 

implements internationally harmonized 

definitions and reporting standards. The 

revisions will improve the utility of IND 

safety reports, reduce the number of 

reports that do not contribute in a 

meaningful way to the developing safety 

profile of the drug, expedite FDA’s 

review of critical safety information, 

better protect human subjects enrolled 

in clinical trials, subject bioavailability 

and bioequivalence studies to safety 

reporting requirements, promote a 

consistent approach to safety reporting 

internationally, and enable the agency 

to better protect and promote public 

health. 

DATES: This rule is effective March 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

For information on IND safety 

reporting for human drug products: 

Janet Norden, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6324, 

Silver Spring, MD 20993–0002, 301– 

796–2500. 

For information on IND safety 

reporting for human biological products: 

Laura Rich, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration,1401 Rockville 

Pike, suite 200N, Rockville, MD 20852– 

1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Rationale for Rulemaking 

B. The Proposed Rule 

II. Overview of the Final Rule 

A. Definitions 

B. Review of Safety Information 

C. Reporting Requirements 

III. Comments on the Proposed Rule 

A. Definitions—Proposed § 312.32(a) 

B. Review of Safety Information— 

Proposed § 312.32(b) 

C. IND Safety Reports (Requirement 

for Minimum Data Set)—Proposed 

§ 312.32(c) 

D. Serious and Unexpected SADR— 

Proposed § 312.32(c)(1)(i) 

E. Alternative Reporting 

Arrangements 

F. Unblinding 

G. Information Sufficient to Consider 

Product Administration Changes— 

Proposed § 312.32(c)(1)(ii) 

H. Submission of Written Reports— 

Proposed § 312.32(c)(1)(iii) 

I. Telephone and Facsimile 

Transmission Safety Reports— 

Proposed § 312.32(c)(2) 

J. Investigations of Marketed Drugs— 

Proposed § 312.32(c)(4) 

K. Followup—Proposed § 312.32(d) 

L. Disclaimer—Proposed § 312.32(e) 

M. Annual Reports 

N. Investigator Reports—Proposed 

§ 312.64(b) 

O. Bioavailability and Bioequivalence 

Requirements—Proposed 

§ 320.31(d) 

P. Reports to Investigators and IRBs 

Q. Miscellaneous Comments 

R. Initial Analysis of Impacts and 

Paperwork Burden Estimates 

IV. Legal Authority 

V. Environmental Impact 

VI. Analysis of Impacts 

A. Need for the Regulation 

B. Costs of the Regulation (to Prepare 

and Submit Safety Reports) 

C. Benefits of the Regulation 

D. Final Regulatory Flexibility 

Analysis 

VII. Paperwork Reduction Act of 1995 

VIII. Executive Order 13132: Federalism 

IX. References 

I. Background 

In the Federal Register of March 14, 

2003 (68 FR 12406), FDA issued a 

proposed rule to revise its regulations 

governing pre- and postmarketing safety 


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