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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