Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11783 

Recovery and Reinvestment Act of 2009 

(ARRA). For ease of reference, the APOE 

will be exclusively referred to by its 

new name in the remainder of this 

notice, even if it is referring to past 

activities. 

The charter will terminate on January 

21, 2013, unless renewed by appropriate 

action. The APOE was chartered under 

42 U.S.C. 222 of the PHSA, as amended. 

The APOE is governed by provisions of 

Public Law 92–463, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory committees. 

Pursuant to the amended charter, the 

APOE will advise the Secretary of 

Health and Human Services and the 

CMS Administrator concerning optimal 

strategies for the following: 

• Developing and implementing 

education and outreach programs for 

individuals enrolled in or eligible for 

Medicare, Medicaid, and CHIP. 

• Enhancing the Federal 

government’s effectiveness in informing 

the Medicare, Medicaid and CHIP 

consumers, providers and stakeholders 

pursuant to education and outreach 

programs of issues regarding these and 

other health coverage programs, 

including the appropriate use of publicprivate partnerships to leverage the 

resources of the private sector in 

educating beneficiaries, providers and 

stakeholders. 

• Expanding outreach to vulnerable 

and underserved communities, 

including racial and ethnic minorities, 

in the context of Medicare, Medicaid, 

and CHIP education programs. 

• Assembling and sharing an 

information base of ‘‘best practices’’ for 

helping consumers evaluate health plan 

options. 

• Building and leveraging existing 

community infrastructures for 

information, counseling and assistance. 

• Drawing the program link between 

outreach and education, promoting 

consumer understanding of health care 

coverage choices and facilitating 

consumer selection/enrollment, which 

in turn support the overarching goal of 

improved access to quality care, 

including prevention services, 

envisioned under health care reform. 

B. Requests for Nominations 

The APOE shall consist of no more 

than 20 members. The Chair shall either 

be appointed from among the 20 

members, or a Federal official will be 

designated to serve as the Chair. The 

charter requires that meetings shall be 

held approximately four times per year. 

Members will be expected to attend all 

meetings. The members and the Chair 

shall be selected from authorities 

knowledgeable in one or more of the 

following fields: 

• Senior citizen advocacy. 

• Outreach to minority communities. 

• Health communications. 

• Disease-related advocacy. 

• Disability policy and access. 

• Health economics research. 

• Health insurers and plans. 

• Health IT. 

• Direct patient care. 

• Matters of labor and retirement. 

Representatives of the general public 

may also serve on the APOE. 

This notice also announces that as of 

January 2011, there are 12 expired terms 

of membership. This notice is an 

invitation to interested organizations or 

individuals to submit their nominations 

for membership on the APOE. The CMS 

Administrator will appoint new 

members to the APOE from among those 

candidates determined to have the 

expertise required to meet specific 

agency needs, and in a manner to ensure 

an appropriate balance of membership. 

We have an interest in ensuring that the 

interests of both women and men, 

members of all racial and ethnic groups, 

and physically challenged individuals 

are adequately represented on the 

APOE. Therefore, we encourage 

nominations of qualified candidates 

who can represent these interests. Any 

interested person may nominate one or 

more qualified persons. 

Current members whose terms 

expired in 2010 or 2011 may be 

considered for reappointment, subject to 

committee service guidelines. 

Each nomination must state that the 

nominee has expressed a willingness to 

serve as a Panel member and must be 

accompanied by a curricula vitae and a 

brief biographical summary of the 

nominee’s experience. 

While we are looking for experts in a 

number of fields, our most critical needs 

are for experts in health disparities, 

State Health Insurance Assistance 

Programs (SHIPs), health insurance 

plans, aging, Web health education, eprescribing, retirement/financial 

planning, health research, public health 

and prevention, caregiving, CHIP, health 

insurance exchanges, and minority 

health education. 

We are requesting that all curricula 

vitae include the following: 

• Date of birth. 

• Place of birth. 

• Title and current position. 

• Professional affiliation. 

• Home and business address. 

• Telephone and fax numbers. 

• E-mail address. 

• List of areas of expertise. 

Phone interviews of nominees may 

also be requested after review of the 

nominations. 

In order to permit an evaluation of 

possible sources of conflict of interest, 

potential candidates will be asked to 

provide detailed information concerning 

such matters as financial holdings, 

consultancies, and research grants or 

contracts. 

Members are invited to serve for 2- 

year terms, contingent upon the renewal 

of the APOE by appropriate action prior 

to its termination. A member may serve 

after the expiration of that member’s 

term until a successor takes office. Any 

member appointed to fill a vacancy for 

an unexpired term shall be appointed 

for the remainder of that term. 

III. Copies of the Charter 

The Secretary’s Charter for the APOE 

is available on the CMS Web site at: 

http://www.cms.gov/FACA/ 

04_APOE.asp, or you may obtain a copy 

of the charter by submitting a request to 

the contact listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 25, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–4754 Filed 2–28–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0265] (formerly 

Docket 2007N–0026) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Canning 

Establishment Registration, Process 

Filing, and Recordkeeping for Acidified 

Foods and Thermally Processed LowAcid Foods in Hermetically Sealed 

Containers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 


srobinson on DSKHWCL6B1PROD with NOTICES
11784 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

DATES: Fax written comments on the 

collection of information by April 4, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0037. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Canning Establishment 

Registration, Process Filing, and 

Recordkeeping for Acidified Foods and 

Thermally Processed Low-Acid Foods 

in Hermetically Sealed Containers— 

(OMB Control Number 0910–0037)— 

Revision 

Under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), FDA is 

authorized to prevent the interstate 

distribution of food products that may 

be injurious to health or that are 

otherwise adulterated, as defined in 

section 402 of the FD&C Act (21 U.S.C. 

342). Under the authority granted to 

FDA by section 404 of the FD&C Act (21 

U.S.C. 344), FDA regulations require 

registration of food processing 

establishments, filing of process or other 

data, and maintenance of processing 

and production records for acidified 

foods and thermally processed low-acid 

foods in hermetically sealed containers. 

These requirements are intended to 

ensure safe manufacturing, processing, 

and packing procedures and to permit 

FDA to verify that these procedures are 

being followed. Improperly processed 

low-acid foods present life-threatening 

hazards if contaminated with foodborne 

microorganisms, especially Clostridium 

botulinum. The spores of C. botulinum 

must be destroyed or inhibited to avoid 

production of the deadly toxin that 

causes botulism. This is accomplished 

with good manufacturing procedures, 

which must include the use of adequate 

heat processes or other means of 

preservation. 

To protect the public health, FDA 

regulations require that each firm that 

manufactures, processes, or packs 

acidified foods or thermally processed 

low-acid foods in hermetically sealed 

containers for introduction into 

interstate commerce register the 

establishment with FDA using Form 

FDA 2541 (§§ 108.25(c)(1) and 

108.35(c)(1) (21 CFR 108.25(c)(1) and 

108.35(c)(1))). In addition to registering 

the plant, each firm is required to 

provide data on the processes used to 

produce these foods, using Form FDA 

2541a for all methods except aseptic 

processing, or Form FDA 2541c for 

aseptic processing of low-acid foods in 

hermetically sealed containers 

(§§ 108.25(c)(2) and 108.35(c)(2)). Plant 

registration and process filing may be 

accomplished simultaneously. Process 

data must be filed prior to packing any 

new product (§§ 108.25(c)(2) and 

108.35(c)(2)). For processors of 

thermally processed low-acid foods in 

hermetically sealed containers, 

operating processes and procedures 

must be posted near the processing 

equipment or made available to the 

operator (§ 113.87(a) (21 CFR 

113.87(a))). 

Regulations in parts 108, 113, and 114 

(21 CFR parts 108, 113, and 114) require 

firms to maintain records showing 

adherence to the substantive 

requirements of the regulations. These 

records must be made available to FDA 

on request. Firms are also required to 

document corrective actions when 

process controls and procedures do not 

fall within specified limits (§§ 113.89, 

114.89, and 114.100(c)); to report any 

instance of potential health-endangering 

spoilage, process deviation, or 

contamination with microorganisms 

where any lot of the food has entered 

distribution in commerce (§ 108.25(d) 

and § 108.35(d) and (e)); and to develop 

and keep on file plans for recalling 

products that may endanger the public 

health (§§ 108.25(e) and 108.35(f)). To 

permit lots to be traced after 

distribution, acidified foods and 

thermally processed low-acid foods in 

hermetically sealed containers must be 

marked with an identifying code 

(§§ 113.60(c) (thermally processed 

foods) and 114.80(b) (acidified foods)). 

These collection of information 

provisions are currently approved under 

OMB control number 0910–0037 

(expires August 31, 2011). In the 

Federal Register of March 14, 2007 (72 

FR 11990), FDA published a proposed 

rule entitled ‘‘Temperature-Indicating 

Devices; Thermally Processed Low-Acid 

Foods Packaged in Hermetically Sealed 

Containers’’ (the proposed rule). This 

document proposed to revise FDA’s 

regulations for thermally processed lowacid foods in part 113 to, among other 

things, provide for the use of 

temperature-indicating devices other 

than mercury-in-glass thermometers 

during processing, require that 

temperature-indicating devices be tested 

for accuracy against a calibrated 

reference device, and to establish 

recordkeeping requirements for 

temperature-indicating devices and 

reference devices maintained by the 

processor. In compliance with the PRA 

(44 U.S.C. 3506(c)(2)(B)), the Agency 

requested public comment on the 

information collection provisions of the 

proposed rule (72 FR 11990 at 12004). 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

entitled ‘‘Temperature-Indicating 

Devices; Thermally Processed Low-Acid 

Foods Packaged in Hermetically Sealed 

Containers’’ (the final rule). The final 

rule revises the information collection 

currently approved under OMB control 

number 0910–0037 by adding 

recordkeeping requirements in new 

§ 113.100(c) and (d). The information to 

be recorded under these regulations is 

related to accuracy tests of temperatureindicating devices and reference devices 

maintained by processors of low-acid 

canned foods. These tests must be 

performed to ensure the accuracy of the 

devices during the processing of these 

foods. If these devices are not accurate, 

the processor cannot ensure that the 

low-acid canned foods it produces are 

safe to eat, and consumers may be 

harmed. The recordkeeping 

requirements of the final rule are 

necessary to document that appropriate 

accuracy tests have been performed 

with the appropriate frequencies for 

each temperature-indicating device and 

each reference device maintained by the 

processor. Records of accuracy tests for 

these devices also help processors 

determine how frequently the devices 

should be tested for accuracy. Much of 

the information is currently generated 

for accuracy tests performed under 

current regulations. However, the 

information may not be recorded as 

required under the final rule. 

Current low-acid canned food 

regulations recommend, but do not 

require, that processors keep records of 

accuracy tests for mercury-in-glass 

thermometers, including test date, 

standard used, method used, and person 

performing the test. The final rule 

requires processors to keep records 

documenting the accuracy of 

temperature-indicating devices 

(including but not limited to mercuryin-glass thermometers) and of reference 

devices that are maintained by the 

processor. These records include the 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11785 

identifier of the device being tested, 

such as its tag or seal; the name of the 

manufacturer of the device; the identity 

of the reference device, equipment, and 

procedures used for the accuracy test 

and to adjust the device or, if an outside 

facility conducts the accuracy test, 

documentation regarding the 

traceability of the accuracy to a National 

Institute of Standards and Technology 

or other national metrology institute 

standard; the identity of the person or 

facility that performed the accuracy test 

and adjusted or calibrated the device; 

the date and results of each accuracy 

test, including the amount of 

adjustment; and the date on or before 

which the next accuracy test must be 

performed. 

In addition to requesting public 

comment on the new recordkeeping 

provisions, the proposed rule also stated 

that FDA had submitted the 

recordkeeping provisions to OMB for 

review (72 FR 11990 at 12005). 

However, due to an administrative error, 

the Agency did not actually do so, and, 

therefore, FDA is submitting them to 

OMB now. Because OMB approval for 

the collections of information in the 

regulations the final rule amends is set 

to expire on August 31, 2011, FDA is 

also submitting those collections (as 

revised by the final rule) for OMB 

review, along with the others currently 

approved under OMB control number 

0910–0037. 

Description of Respondents: The 

respondents to this information 

collection are commercial processors 

and packers of acidified foods and 

thermally processed low-acid foods in 

hermetically sealed containers. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Form No. 21 CFR section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Form FDA 2541 (Registration) 108.25 and 108.35 .... 515 1 515 .17 88 

Form FDA 2541a (Process Filing).108.25 and 108.35 .... 1,489 8 .62 12,835 .333 4,274 

Form FDA 2541c (Process Filing).108.35 ....................... 84 7 .77 653 .75 490 

Total .................................. .................................... ........................ .......................... ........................ .......................... 4,852 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA bases its estimates of the number 

of respondents and the hours per 

response on its experience with 

registration and process filing and on 

information from industry. FDA 

estimates the total burden of registration 

under §§ 108.25 and 108.35 to be 88 

hours (515 respondents × 1 annual 

response × 0.17 hours = 87.55 hours, 

rounded to 88 hours). FDA estimates the 

total burden of process filing on Form 

FDA 2541a under §§ 108.25 and 108.35 

to be 4,274 hours (1,489 respondents × 

8.62 annual responses × 0.333 hours = 

4,274.12 hours, rounded to 4,274 hours). 

FDA estimates the total burden of 

process filing on Form FDA 2541c 

under § 108.35 to be 490 hours (84 

respondents × 7.77 annual responses × 

0.75 hours = 489.51 hours, rounded to 

490 hours). The reporting burden for 

§ 108.25(d) and § 108.35(d) and (e) is 

minimal because notification of 

spoilage, process deviation, or 

contamination of product in distribution 

occurs less than once per year. Most 

firms discover these problems before the 

product is distributed and, therefore, are 

not required to report the occurrence. 

To avoid double-counting, estimates for 

§§ 108.25(g) and 108.35(h) have not 

been included because they merely 

cross-reference recordkeeping 

requirements contained in parts 113 and 

114. 

FDA permits electronic registration 

and filing on the Internet. The electronic 

submission capability of the Low Acid 

Canned Food (LACF) Program entitled 

eLACF was the second major 

registration application to be supported 

by and integrated under the FDA 

Unified Registration and Listing System 

(FURLs). Food canning establishments 

can request an electronic account by 

sending an e-mail to lacf@fda.hhs.gov. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR part/section Number of 

recordkeepers 

Annual 

frequency of 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

21 CFR Parts 113 and 114 ................................................. 9,500 1 9,500 250 2,375,000 

Burden added by new § 113.100(c) and (d) ........................ 4,225 15 63,375 0.0097 615 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,375,615 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA received six letters, each 

containing one or more comments on 

the proposed rule. Although the Agency 

did not identify any comments referring 

specifically to the PRA, several 

comments discussed the proposed 

recordkeeping provisions. FDA has 

summarized and responded to these 

comments in section II of the final rule 

(Comments 1, 4, 11 through 13, and 18). 

None of the comments on the proposed 

rule suggested that we modify our 

burden estimates for the new 

information collection provisions. Thus, 

we have not changed our estimates of 

the annual frequency per recordkeeping 

or the hours per record. We have, 

however, increased the estimated 

number of recordkeepers to reflect 

growth in the low-acid canned food 

processing industry since the 2007 

proposed rule. 

Currently, there are 9,491 active firms 

in the LACF database, which 

encompasses processors of low-acid 


srobinson on DSKHWCL6B1PROD with NOTICES
11786 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

canned food, processors of acidified 

food, and processors of both types of 

food. Thus, we estimate the number of 

processors keeping records under parts 

113 and 114 to be 9,500, as shown in 

table 2, row 1 of this document. In the 

final rule, we estimated that there are 

approximately 8,450 foreign and 

domestic low-acid canned food 

processing establishments. This 

estimate, which does not encompass 

establishments that process only 

acidified foods (because such processors 

are not affected by the final rule), was 

based on data in the LACF database as 

of September 2009. As discussed in the 

explanation of the recordkeeping 

estimate for the final rule in the 

following paragraphs, our estimate 

assumes that half of the LACF industry 

currently does not record all of the 

device accuracy testing information that 

the final rule requires. Thus, as shown 

in table 2, row 2 of this document, we 

estimate that 4,225 low-acid canned 

food manufacturers that are not 

currently keeping the records that are 

required under the final rule will begin 

to keep such records to comply with the 

final rule when it becomes effective. 

FDA bases its estimates of the number 

of recordkeepers and the hours per 

record on its experience and on 

information from industry. FDA 

estimates that it takes 250 hours per 

respondent to comply with the 

recordkeeping requirements in parts 113 

and 114. In table 2, row 1 of this 

document, FDA estimates the total 

burden of recordkeeping under parts 

113 and 114 before the effective date of 

the final rule to be 2,375,000 hours 

(9,500 respondents × 250 hours = 

2,375,000 hours). Table 2, row 2 reports 

the average annual recordkeeping 

burden of the final rule. The burden of 

the recordkeeping requirement of the 

final rule consists of the set-up time 

required to design and establish a form 

for recording the required information, 

and the additional hours of labor 

needed to record the information. The 

set-up time required for designing a new 

recordkeeping form is assumed to be 

minimal because we estimate that only 

a few data elements required in the final 

rule are currently unreported by some 

processors and that only small 

modifications to a processor’s 

recordkeeping form would be required 

to accommodate the additional data 

elements. 

We estimate that the amount of time 

needed to comply with the 

recordkeeping requirements of the final 

rule will be small because current 

industry practice is to keep track of 

most, if not all, of this information. 

Because current incentives to track 

accuracy of mercury-in-glass 

thermometers may vary across the 

industry, however, some information 

that is currently generated during 

accuracy tests may not be recorded as 

required under the final rule. Thus, we 

assume there will be a burden incurred 

from the final rule to record information 

that is currently generated, but not 

recorded. 

We assume that half of the industry 

currently does not record all of the 

device accuracy testing information that 

the final rule requires. We further 

assume that current practice by these 

firms is to leave unrecorded 1 to 4 

separate pieces of information required 

under the final rule, and that each piece 

of information takes between 10 and 15 

seconds to record. Consequently, we 

estimate that half of all low-acid canned 

food manufacturers will spend between 

10 seconds and 1 minute (i.e., 1 × 10 

seconds and 4 × 15 seconds) per device 

to record information required in the 

final rule. 

Based on a survey conducted by FDA 

between 1992 and 1993 of mercury-inglass thermometer calibration in the 

low-acid canned food industry, we 

estimate that low-acid food firms use an 

average of 10 temperature-indicating 

devices, including reference devices. 

We estimate that 4,225 low-acid canned 

food manufacturers (half of the 

industry) currently do not fully record 

the accuracy test results required by the 

final rule. Because the regulations 

specify that each device must be tested 

upon installation and at least once per 

year thereafter, or more frequently if 

necessary to ensure accuracy, we 

estimate that each device requires 1 to 

2 tests per year (midpoint of 1.5 tests 

per year). We therefore estimate the 

annual frequency per recordkeeping to 

be 15 (i.e., 10 devices × 1.5 tests per 

year). We estimate the burden for 

recording the additional information to 

be between 10 and 60 seconds per 

device (midpoint of 35 seconds or 

0.0097 hours per device). Therefore, the 

estimated total annual burden in hours 

for the recordkeeping requirements of 

the final rule is approximately 615 

hours (63,375 × 0.0097 = 614.7 hours, 

rounded to 615 hours). Thus, the final 

rule increases the total burden of this 

information collection by approximately 

0.3 percent, from 2,375,000 hours to 

2,375,615 hours. 

Dated: February 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–4474 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0583] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Radioactive Drug 

Research Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 4, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0053. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Radioactive Drug Research 

Committees—(OMB Control Number 

0910–0053)—Extension 

Under sections 201, 505, and 701 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321, 355, and 371), FDA 

has the authority to issue regulations 

governing the use of radioactive drugs 

for basic scientific research. Section 

361.1 (21 CFR 361.1) sets forth specific 

regulations regarding the establishment 

and composition of Radioactive Drug 

Research Committees and their role in 

approving and monitoring basic 

research studies utilizing 

radiopharmaceuticals. No basic research 


srobinson on DSKHWCL6B1PROD with NOTICES