Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Proposed Rules 80011 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

1. The authority citation for part 240 

is amended by adding the following 

citation in numerical order to read as 

follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78o– 

4, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 

78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b– 

3, 80b–4, 80b–11, and 7201 et seq.; 18 U.S.C. 

1350; and 12 U.S.C. 5221(e)(3), unless 

otherwise noted. 

* * * * * 

Section 240.3Cg–1 is also issued under 

Public Law 111–203, § 763, 124 Stat. 1841 

(2010). 

* * * * * 

2. Add § 240.3Cg–1 to read as follows: 

§ 240.3Cg–1 Notice to the Commission 

[and Financial Entity Exemption]. 

(a) A counterparty to a security-based 

swap that invokes the clearing 

exception under Section 3C(g)(1) of the 

Act (15 U.S.C. 78c–3(g)(1)) shall satisfy 

the requirements of Section 3C(g)(1)(C) 

of the Act (15 U.S.C. 78c–3(g)(1)(C)) by 

delivering or causing to be delivered the 

following additional information to a 

registered security-based swap data 

repository (or, if none is available, to the 

Commission) in the form and manner 

required for delivery of the information 

separately specified under § 242.901(d) 

of Regulation SBSR of this chapter: 

(1) The identity of the counterparty 

relying on the clearing exception; 

(2) Whether the counterparty invoking 

the clearing exception is a ‘‘financial 

entity’’ as defined in Section 3C(g)(3) of 

the Act (15 U.S.C. 78c–3(g)(3)); 

(3) Whether the counterparty invoking 

the clearing exception is a finance 

affiliate meeting the requirements 

described in Section 3C(g)(4) of the Act 

(15 U.S.C. 78c–3(g)(4)); 

(4) Whether the security-based swap 

is used by the counterparty invoking the 

clearing exception to hedge or mitigate 

commercial risk as defined in 

§ 240.3a67–4 of this chapter; 

(5) Whether the counterparty invoking 

the clearing exception generally expects 

to meet its financial obligations 

associated with the security-based swap 

by using any of the following: 

(i) A written credit support 

agreement; 

(ii) A written agreement to pledge or 

segregate assets; 

(iii) A written third-party guarantee; 

(iv) Solely the counterparty’s 

available financial resources; or 

(v) Means other than those described 

in paragraphs (a)(5)(i), (ii), (iii), and (iv) 

of this section; 

(6) Whether the counterparty invoking 

the clearing exception is an issuer of 

securities registered under Section 12 

(15 U.S.C. 78l) or subject to reporting 

requirements pursuant to Section 15(d) 

(15 U.S.C. 78o(d)) of the Act, and if so: 

(i) The relevant Commission Central 

Index Key number for the counterparty 

invoking the clearing exception; and 

(ii) Whether an appropriate committee 

of the board of directors (or equivalent 

body) of the counterparty invoking the 

clearing exception has reviewed and 

approved the decision to enter into a 

security-based swap subject to the 

clearing exception. 

Additional Rule Text Under 

Consideration by the Commission 

(b) For purposes of Section 

3C(g)(1)(A) of the Act (15 U.S.C. 78c– 

3(g)(1)(A)), any person specified in 

paragraph (c) of this section that would 

be a financial entity within the meaning 

of the term in Section 3C(g)(3)(A) of the 

Act (15 U.S.C. 78c–3(g)(3)(A)) solely 

because of Section 3C(g)(3)(A)(viii) of 

the Act (15 U.S.C. 78c–3(g)(3)(A)(viii)) 

shall be exempt from the definition of 

financial entity. 

(c) A person shall be eligible for the 

exemption in paragraph (b) of this 

section if such person: 

(1) Is organized as a bank, as defined 

in Section 3(a)(6) of the Act (15 U.S.C. 

78c), the deposits of which are insured 

by the Federal Deposit Insurance 

Corporation, a savings association, as 

defined in section 3(b) of the Federal 

Deposit Insurance Act (12 U.S.C. 1831), 

the deposits of which are insured by the 

Federal Deposit Insurance Corporation, 

a farm credit system institution 

chartered under the Farm Credit Act of 

1971 (12 U.S.C. 2001), or an insured 

Federal credit union or State-chartered 

credit union under the Federal Credit 

Union Act (12 U.S.C. 1752); and 

(2) Has total assets of $10,000,000,000 

or less on the last day of the most recent 

fiscal year. 

By the Commission. 

Dated: December 15, 2010. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2010–31973 Filed 12–20–10; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 58 

[Docket No. FDA–2010–N–0548] 

Good Laboratory Practice for 

Nonclinical Laboratory Studies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA) is seeking 

comment on whether to amend the 

regulations governing good laboratory 

practices (GLPs). The Agency decided 

that to require a GLP quality system for 

all facilities/laboratories, as well as to 

more completely address nonclinical 

studies as they are presently conducted, 

the Agency would need to modify the 

existing regulations. 

DATES: Submit either electronic or 

written comments by February 22, 2011. 

ADDRESSES: You may submit comments, 

identified by the Docket No. FDA–2010– 

N–0548, by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in the brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
80012 Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Proposed Rules 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: C. T. 

Viswanathan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5346, 

Silver Spring, MD 20993–0002, 301– 

796–3394. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s GLP regulations, part 58 (21 

CFR part 58), were finalized on 

December 22, 1978 (43 FR 60013). As 

stated in its scope (§ 58.1), this 

regulation prescribes good laboratory 

practices for conducting nonclinical 

laboratory studies that support or are 

intended to support applications for 

research or marketing permits for 

products regulated by FDA, including 

food and color additives, animal food 

additives, human and animal drugs, 

medical devices for human use, 

biological products, and electronic 

products. A nonclinical laboratory 

study, as defined in § 58.3(d), is an 

* * * in vivo or in vitro experiment in 

which test articles are studied 

prospectively in test systems under 

laboratory conditions to determine their 

safety. The term does not include 

studies utilizing human subjects or 

clinical studies or field trials in animals. 

[It also] does not include basic 

exploratory studies carried out to 

determine whether a test article has any 

potential utility or to determine 

physical or chemical characteristics of a 

test article. 

The conduct of nonclinical laboratory 

studies has changed markedly since 

issuance of this regulation in 1978. For 

example, it is presently common for 

nonclinical laboratory studies to be 

conducted across multiple testing 

facilities, or sites (multisite studies). 

When the regulation was originally 

finalized, however, most studies were 

conducted within a single facility. In 

addition, laboratories have expanded 

the use of electronic technology, both 

for laboratory instrumentation and as a 

means for collecting, storing, and 

reporting study data. Current part 58 

does not specifically describe these 

modern arrangements and advances. 

In 2006, FDA announced its Human 

Subject Protection/Bioresearch 

Monitoring (HSP/BIMO) initiative 

aimed at modernizing the Agency’s 

regulations and policies governing the 

conduct of studies used to support 

submissions to FDA. In response to the 

announcement of the HSP/BIMO 

initiative, FDA received stakeholder 

recommendations that included 

suggestions for the revision of part 58. 

In 2007, FDA established an Agencywide GLP working group (WG) to 

evaluate the existing regulation and 

determine if regulatory revision and/or 

guidance should be pursued. The WG 

gathered information as to the needs of 

each FDA center with regard to 

nonclinical laboratory studies, reviewed 

suggestions from external sources, 

conferred with the Environmental 

Protection Agency (EPA) which has a 

similar regulation, and performed a 

thorough evaluation of the existing 

regulations. The WG concluded that to 

ensure the integrity of the data in all 

nonclinical laboratory studies submitted 

to FDA, nonclinical laboratory facilities 

that conduct these studies need to 

follow a GLP quality system approach. 

Currently, the regulations governing 

nonclinical laboratory studies do not 

use such an approach consistently 

throughout part 58. A GLP quality 

system would allow nonclinical 

laboratories to develop standard 

operating procedures consistent with 

their specific operational needs as long 

as they satisfy regulatory requirements 

aimed at ensuring data integrity. The 

WG decided that to require a GLP 

quality system for all facilities/ 

laboratories, as well as to more 

completely address nonclinical studies 

as they are presently conducted, the 

Agency would need to modify the 

existing regulations. 

II. Agency Request for Information 

FDA is soliciting public comments 

about whether to modify the existing 

regulations, and in particular about the 

areas FDA has identified as potentially 

appropriate for revision, as follows: 

1. GLP Quality System 

While many of the requirements of 

the existing regulation are consistent 

with a GLP quality system, FDA 

believes that modifications may be 

necessary to incorporate all basic 

elements needed for a comprehensive 

GLP quality system, such as that set 

forth in the internationally recognized 

standard, Quality management 

systems—Requirements ISO 9001, 

available from the International 

Organization for Standardization (ISO) 

at: http://www.iso.org/iso/home.html. 

Ultimately, any GLP quality system 

proposed for a facility must be capable 

of ensuring the integrity of resulting 

data. FDA is considering whether to 

include in the regulations a core set of 

essential elements for such a GLP 

quality system, including specifically 

mentioning management responsibility 

for all activities at the facility and 

specifying a requirement for standard 

operating procedures for all essential 

functions. 

2. Multisite Studies 

It is currently common practice for 

nonclinical laboratory studies to be 

performed across multiple sites 

(multisite studies), rather than for a 

single facility to conduct all aspects/ 

phases of a study. FDA is considering 

revising the GLP regulations to 

specifically address the use of multisite 

studies through the addition of specific 

definitions to describe personnel and 

study aspects specific to multisite 

studies, e.g., by requiring that an 

individual be designated as the 

responsible person for each site of a 

multisite study. Such an individual 

would be responsible for any phase(s) of 

the study conducted at the site and 

would report to the study director. 

3. Electronic/Computerized Systems 

Since the regulation was finalized, 

many laboratory systems have become 

fully automated. In addition, many 

facilities now employ computerized 

systems for managing general laboratory 

functions as well as for instrumentation 

in which such systems are integral 

components. While the present 

regulation does not preclude such 

electronic systems, several of the 

current regulatory requirements are 

more consistent with paper-based 

systems (e.g., an individual as archivist 

§ 58.190(c)); maintenance of copies of 

study protocols and the Master 

Schedule by the quality assurance unit 

(§ 58.35(b)(1) and (b)(2))). FDA is 

considering updating the regulation to 

reflect the use of electronic and 

computerized systems. FDA believes 

that any modifications to the regulation 

to reference electronic/computerized 

systems should be general, to 

accommodate changes and advances in 

technology. 

4. Sponsor Responsibilities 

Whether nonclinical laboratory 

studies are conducted by a sponsor or at 

a contracted facility, FDA believes that 

the study sponsor should clearly have 

responsibilities that the present 

regulation does not specifically 

mention, such as development and/or 

approval of study protocols. FDA is 

therefore considering amending the 

regulations to include additional 

specific responsibilities of sponsors of 

nonclinical laboratory studies. 

5. Animal Welfare 

In the United States, the Animal 

Welfare Act (7 U.S.C 2131–2159) 

governs the treatment and use of 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Proposed Rules 80013 

animals, including their use for research 

purposes. FDA is soliciting comments 

regarding whether and how to receive 

documentation of compliance with 

these existing statutory provisions or 

comparable international standards 

governing the ethical and humane use of 

laboratory animals in nonclinical 

laboratory studies. This issue is not 

specifically addressed in the present 

regulation. 

6. Information on Quality Assurance 

Inspectional Findings 

When an FDA bioresearch monitoring 

(BIMO) inspection of a nonclinical 

study identifies problems, FDA often 

finds it difficult to determine whether 

the quality assurance unit (QAU) failed 

to adequately inspect the study, or 

whether the QAU made 

recommendations for corrective actions 

and management did not adequately 

respond. FDA is considering the 

addition of a requirement that the QAU 

prepare a yearly summary of general 

inspectional findings that would reveal 

problems that are not necessarily studyspecific and that includes the 

recommendations made to management 

to resolve those problems. Such a report 

would be maintained at the facility and 

be made available to FDA upon request, 

usually during the course of a BIMO 

inspection. 

7. Process-Based Systems Inspections 

A number of procedures used in 

conducting a particular nonclinical 

laboratory study are common across 

many or even most studies conducted at 

the facility. Facilities often find it more 

resourceful to periodically inspect such 

procedures during systems inspections 

rather than repetitively as part of each 

study-specific inspection, as currently 

required in § 58.35(b). For example, it 

may be appropriate to periodically 

inspect procedures such as slide 

preparation for pathology studies as part 

of a facility’s process-based systems 

inspections rather than for each study. 

FDA therefore is considering permitting 

a combination of systems inspections 

and study-specific inspections. The 

results of the appropriate systems 

inspection(s) would be referenced in the 

study-specific inspection reports 

relevant to those aspects of the 

procedures for the study under 

inspection. 

8. Test and Control Article Information 

When reviewing and inspecting 

nonclinical laboratory studies, 

particularly those submitted for new 

drugs (human and animal), basic 

information about the test article, such 

as strength, purity, stability, and for 

mixtures thereof, concentration and 

uniformity, is often absent from the 

laboratory’s records, therefore 

precluding appropriate interpretation of 

the study results. Although the current 

regulations require that these 

parameters be determined (§ 58.105(a) 

and (b) and § 58.113(a)), the regulations 

do not specify who is to receive this 

information or include a timeframe for 

delivery of the information to the 

facility performing the nonclinical 

testing. FDA is therefore considering 

additional requirements under the 

sections in the regulations discussing 

test and control characterization 

(§ 58.105) and mixtures of articles with 

carriers (§ 58.113), including timeframes 

for provision of this information to the 

study director. 

In addition, sponsors have requested 

the ability to cite compliance with the 

applicable good manufacturing 

requirements (i.e, parts 210 and 211, etc. 

as relevant) regarding the specifications, 

quality, and integrity of the test article. 

FDA is considering whether to accept 

compliance with either the specifics 

that would be required under a revised 

part 58, subpart F or the relevant good 

manufacturing requirements. 

9. Sample Storage Container Retention 

FDA’s regulations currently require 

that facilities maintain test article 

storage containers for the duration of the 

study (21 CFR 58.105(c)). FDA believes 

that compliance with the regulatory 

requirements for the handling of test 

and control articles, which include 

documentation of receipt, distribution, 

and use of each batch (§ 58.107(d)) 

provides adequate information about the 

use and integrity of study samples. 

Therefore, FDA is considering 

eliminating the requirement at 

§ 58.105(c). 

FDA welcomes comments from all 

interested persons on these issues and 

any other concerns related to the current 

GLP regulations, including 

recommendations as to the best 

method(s) for addressing such concerns. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

This advance notice of proposed 

rulemaking is issued under section 201 

et al. of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321 et al.) and 

under authority of the Commissioner of 

Food and Drugs. 

Dated: December 15, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31888 Filed 12–20–10; 8:45 am] 

BILLING CODE 4160–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 10–2279; MB Docket No. 10–65; RM– 

10595] 

Radio Broadcasting Services; Jewett, 

TX 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule; dismissal. 

SUMMARY: At the petitioner’s request, the 

Audio Division has dismissed the 

proposal of Charles Crawford to allot 

Channel 232A at Jewett, Texas. 

Crawford had filed a petition for rule 

making proposing the allotment of 

Channel 232A at Jewett, Texas, as the 

community’s first local FM transmission 

service. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Dupont, Media Bureau, (202) 

418–2180. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 10–65, RM– 

10595, adopted December 1, 2010, and 

released December 3, 2010. The full text 

of this Commission decision is available 

for inspection and copying during 

normal business hours in the FCC 

Reference Information Center, Portals II, 

445 12th Street, SW., Room CY–A257, 

Washington, DC 20554. The complete 

text of this decision also may be 

purchased from the Commission’s 

duplicating contractor, Best Copy and 

Printing, Inc., 445 12th Street, SW., 

Room CY–B402, Washington, DC 20554, 

(800) 378–3160, or via the company’s 

Web site, http://www.bcpiweb.com. This 

document is not subject to the 

Congressional Review Act. The 

Commission is, therefore, not required 

to send a copy of this Report and Order 

in a report to be sent to Congress and 

the Government Accountability Office 

pursuant to the Congressional Review 

Act, see U.S.C. 801(a)(1)(A), because the 

proposed rule was dismissed. 

Federal Communications Commission. 

John A. Karousos, 

Assistant Chief, Audio Division, Media 

Bureau. 

[FR Doc. 2010–31997 Filed 12–20–10; 8:45 am] 

BILLING CODE 6712–01–P 


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