Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Rules and Regulations 53813 

A review of historical information and 

preliminary information pertaining to 

the upcoming fiscal period indicates 

that the Oregon-Washington grower 

price for the 2011–2012 fiscal period 

could range between $216 and $283 per 

ton of processed pears. Therefore, the 

estimated assessment revenue for the 

2011–2012 fiscal period as a percentage 

of total grower revenue could range 

between 3.58 and 2.73 percent. 

This action decreases the assessment 

obligation imposed on handlers. 

Assessments are applied uniformly on 

all handlers, and some of the costs may 

be passed on to producers. However, 

decreasing the assessment rate reduces 

the burden on handlers, and may reduce 

the burden on producers. 

In addition, the Committee’s meeting 

was widely publicized throughout the 

Oregon-Washington pear industry and 

all interested persons were invited to 

attend the meeting and participate in 

Committee deliberations on all issues. 

Like all Committee meetings, the June 2, 

2011, meeting was a public meeting and 

all entities, both large and small, were 

able to express views on this issue. 

Finally, interested persons are invited to 

submit comments on this interim rule, 

including the regulatory and 

informational impacts of this action on 

small businesses. 

In accordance with the Paperwork 

Reduction Act of 1991 (44 U.S.C. 

Chapter 35), the order’s information 

collection requirements have been 

previously approved by the Office of 

Management and Budget (OMB) and 

assigned OMB No. 0581–0189, Generic 

Fruit Crops. No changes in those 

requirements as a result of this action 

are anticipated. Should any changes 

become necessary, they would be 

submitted to OMB for approval. 

This action imposes no additional 

reporting or recordkeeping requirements 

on either small or large OregonWashington processed pear handlers. As 

with all Federal marketing order 

programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this rule. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

MarketingOrdersSmallBusinessGuide. 

Any questions about the compliance 

guide should be sent to Laurel May at 

the previously mentioned address in the 

FOR FURTHER INFORMATION CONTACT

section. 

After consideration of all relevant 

material presented, including the 

information and recommendation 

submitted by the Committee and other 

available information, it is hereby found 

that this rule, as hereinafter set forth, 

will tend to effectuate the declared 

policy of the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect, and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) The 2011–2012 fiscal 

period began on July 1, 2011, and the 

marketing order requires that the rate of 

assessment for each fiscal period apply 

to all assessable pears handled during 

such fiscal period; (2) this action 

decreases the assessment rate for 

assessable processed pears beginning 

with the 2011–2012 fiscal period; (3) 

handlers are aware of this action which 

was unanimously recommended by the 

Committee at a public meeting and is 

similar to other assessment rate actions 

issued in past years; and (4) this interim 

rule provides a 60-day comment period, 

and all comments timely received will 

be considered prior to finalization of 

this rule. 

List of Subjects in 7 CFR Part 927 

Marketing agreements, Pears, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, 7 CFR part 927 is amended as 

follows: 

PART 927—PEARS GROWN IN 

OREGON AND WASHINGTON 

■ 1. The authority citation for 7 CFR 

part 927 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. In § 927.237, the introductory text 

and paragraph (a) are revised to read as 

follows: 

§ 927.237 Processed pear assessment 

rate. 

On and after July 1, 2011, the 

following base rates of assessment for 

pears for processing are established for 

the Processed Pear Committee: 

(a) $7.73 per ton for any or all 

varieties or subvarieties of pears for 

canning classified as ‘‘summer/fall’’ 

excluding pears for other methods of 

processing; 

* * * * * 

Dated: August 19, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–22115 Filed 8–29–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 993 

[Doc. No. AMS–FV–11–0068; FV11–993–1 

IR] 

Dried Prunes Produced in California; 

Decreased Assessment Rate 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: This rule decreases the 

assessment rate established for the 

Prune Marketing Committee 

(Committee) for the 2011–12 and 

subsequent crop years from $0.27 to 

$0.22 per ton of salable dried prunes 

handled. The Committee locally 

administers the marketing order which 

regulates the handling of dried prunes 

produced in California. Assessments 

upon dried prune handlers are used by 

the Committee to fund reasonable and 

necessary expenses of the program. The 

crop year begins August 1 and ends July 

31. The assessment rate will remain in 

effect indefinitely unless modified, 

suspended, or terminated. 

DATES: Effective August 31, 2011. 

Comments received by October 31, 

2011, will be considered prior to 

issuance of a final rule. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this rule. Comments must be 

sent to the Docket Clerk, Marketing 

Order Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, 1400 

Independence Avenue, SW., STOP 

0237, Washington, DC 20250–0237; Fax: 

(202) 720–8938; or Internet: http:// 

www.regulations.gov. Comments should 

reference the document number and the 

date and page number of this issue of 

the Federal Register and will be 

available for public inspection in the 

Office of the Docket Clerk during regular 

business hours, or can be viewed at: 

http://www.regulations.gov. All 

comments submitted in response to this 

rule will be included in the record and 


srobinson on DSK4SPTVN1PROD with RULES
53814 Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Rules and Regulations 

will be made available to the public. 

Please be advised that the identity of the 

individuals or entities submitting the 

comments will be made public on the 

Internet at the address provided above. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Ricci or Kurt Kimmel, California 

Marketing Field Office, Marketing Order 

Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA; 

Telephone: (559) 487–5901, Fax: (559) 

487–5906, or E-mail: 

Andrea.Ricci@ams.usda.gov or 

Kurt.Kimmel@ams.usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Laurel May, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720– 

2491, Fax: (202) 720–8938, or E-mail: 

Laurel.May@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This rule 

is issued under Marketing Agreement 

No. 110 and Order No. 993, both as 

amended (7 CFR part 993), regulating 

the handling of dried prunes produced 

in California, hereinafter referred to as 

the ‘‘order.’’ The order is effective under 

the Agricultural Marketing Agreement 

Act of 1937, as amended (7 U.S.C. 601– 

674), hereinafter referred to as the 

‘‘Act.’’ 

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Order 

12866. 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. Under the marketing order now 

in effect, California dried prune 

handlers are subject to assessments. 

Funds to administer the order are 

derived from such assessments. It is 

intended that the assessment rate as 

issued herein will be applicable to all 

assessable dried prunes beginning 

August 1, 2011, and continue until 

amended, suspended, or terminated. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. Such 

handler is afforded the opportunity for 

a hearing on the petition. After the 

hearing, USDA would rule on the 

petition. The Act provides that the 

district court of the United States in any 

district in which the handler is an 

inhabitant, or has his or her principal 

place of business, has jurisdiction to 

review USDA’s ruling on the petition, 

provided an action is filed not later than 

20 days after the date of the entry of the 

ruling. 

This rule decreases the assessment 

rate established for the Committee for 

the 2011–12 and subsequent crop years 

from $0.27 per to $0.22 per ton of 

salable dried prunes. 

The California dried prune marketing 

order provides authority for the 

Committee, with the approval of USDA, 

to formulate an annual budget of 

expenses and collect assessments from 

handlers to administer the program. The 

members of the Committee are 

producers and handlers of California 

dried prunes. They are familiar with the 

Committee’s needs and with the costs 

for goods and services in their local area 

and are thus in a position to formulate 

an appropriate budget and assessment 

rate. The assessment rate is formulated 

and discussed in a public meeting. 

Thus, all directly affected persons have 

an opportunity to participate and 

provide input. 

For the 2010–11 and subsequent crop 

years, the Committee recommended, 

and USDA approved, an assessment rate 

that would continue in effect from crop 

year to crop year unless modified, 

suspended, or terminated by USDA 

upon recommendation and information 

submitted by the Committee or other 

information available to USDA. 

The Committee met on June 16, 2011, 

and unanimously recommended 2011– 

12 expenditures of $46,497 and an 

assessment rate of $0.22 per ton of 

salable dried prunes. In comparison, last 

year’s budgeted expenditures were 

$55,548. The assessment rate of $0.22 is 

$0.05 lower than the rate currently in 

effect. 

The Committee unanimously 

recommended the lower assessment rate 

because of a substantial decrease in 

salaries and wages expense. The current 

excess funds carried forward and 

estimated interest income combined 

with the funds generated from the 

decreased assessment rate and 

decreased crop is expected to provide 

adequate income to cover anticipated 

2011–12 year expenses. 

The major expenditures 

recommended by the Committee for the 

2011–12 year include $20,993 for 

salaries and wages expense, $9,783 for 

operating expenses, and $15,721 for 

contingences. Budgeted expenses for 

these items in 2010–11 were $31,781, 

$10,730, and $13,037, respectively. 

The assessment rate recommended by 

the Committee was derived by 

considering the excess funds carried 

forward into the 2011–12 crop year, the 

estimated interest income, the estimated 

salable tons of California dried prunes, 

and handler assessment revenue needed 

to meet anticipated expenses. Excess 

funds carried forward are expected to be 

about $19,650 and interest income is 

estimated at $7. Dried prune production 

for the year is estimated at 122,000 

salable tons, which should provide 

$26,840 in assessment income. In 

addition, most of the Committee’s 

expenses reflect its portion of the joint 

administrative costs of the Committee 

and the California Dried Plum Board 

(CDPB). Based on the Committee’s 

reduced activities in the recent years, it 

is funding only 5 percent of the shared 

expenses of the two programs. This 

funding level is similar to that of last 

year. The Committee believes that the 

current excess funds carried forward 

from the 2010–11 crop year and 

estimated interest income combined 

with funds generated from the lower 

2011–12 assessment rate and decreased 

crop will be adequate to cover its 

anticipated 2011–2012 expenses of 

$46,497. 

The Committee is authorized under 

§ 993.81(c) of the order to use excess 

assessment funds from the 2010–11 crop 

year (currently estimated at $19,650) for 

up to 5 months beyond the end of the 

crop year to meet the 2011–12 crop year 

expenses. At the end of the 5 months, 

the Committee either refunds or credits 

excess funds to handlers. 

The assessment rate established in 

this rule will continue in effect 

indefinitely unless modified, 

suspended, or terminated by USDA 

upon recommendation and information 

submitted by the Committee or other 

available information. 

Although this assessment rate is 

effective for an indefinite period, the 

Committee will continue to meet prior 

to or during each crop year to 

recommend a budget of expenses and 

consider recommendations for 

modification of the assessment rate. The 

dates and times of Committee meetings 

are available from the Committee or 

USDA. Committee meetings are open to 

the public and interested persons may 

express their views at these meetings. 

USDA will evaluate Committee 

recommendations and other available 

information to determine whether 

modification of the assessment rate is 

needed. Further rulemaking will be 

undertaken as necessary. The 

Committee’s 2011–12 budget and those 

for subsequent crop years will be 

reviewed and, as appropriate, approved 

by USDA. 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Rules and Regulations 53815 

Initial Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601–612), the Agricultural 

Marketing Service (AMS) has 

considered the economic impact of this 

rule on small entities. Accordingly, 

AMS has prepared this initial regulatory 

flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions in order 

that small businesses will not be unduly 

or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. 

There are approximately 800 

producers of dried prunes in the 

California area and approximately 21 

handlers subject to regulation under the 

marketing order. Small agricultural 

producers are defined by the Small 

Business Administration (13 CFR 

121.201) as those having annual receipts 

less than $750,000, and small 

agricultural service firms are defined as 

those whose annual receipts are less 

than $7,000,000. 

Committee data indicates that about 

64 percent of the handlers ship under 

$7,000,000 worth of dried prunes. 

Dividing the average dried prune crop 

value for 2010 reported by the National 

Agricultural Statistics Service (NASS) of 

$149,860,000 by the number of 

producers (800) yields the average 

annual producer revenue estimate of 

about $187,325. Thus, the majority of 

handlers and California dried prune 

producers may be classified as small 

entities. 

This rule decreases the assessment 

rate established for the Committee and 

collected from handlers for the 2011–12 

and subsequent crop years from $0.27 to 

$0.22 per ton of salable dried prunes. 

The Committee unanimously 

recommended 2011–12 estimated 

expenses of $46,497 and a decreased 

assessment rate of $0.22 per ton of 

salable dried prunes. 

The quantity of assessable dried 

prunes for the 2011–12 crop year is 

estimated at 122,000 tons. Thus, the 

$0.22 rate should provide $26,840 in 

assessment income. The current excess 

funds carried forward and estimated 

interest income combined with funds 

generated from the decreased 

assessment rate and decreased crop is 

expected to provide adequate income to 

cover anticipated 2011–12 crop year 

expenses. 

The major expenditures 

recommended by the Committee for the 

2011–12 crop year include $20,993 for 

salaries and wages expense, $9,783 for 

operating expenses, and $15,721 for 

contingences. Budgeted expenses for 

these items in 2010–11 were $31,781, 

$10,730, and $13,037, respectively. 

The Committee unanimously 

recommended the lower assessment rate 

because of a substantial decrease in 

salaries and wages expense. The current 

excess funds carried forward and 

estimated interest income combined 

with the funds generated from the 

decreased assessment rate and 

decreased crop are expected to provide 

adequate income to cover anticipated 

2011–12 year expenses. 

The Committee discussed alternatives 

to this rule, including alternative 

expenditure levels, but determined that 

the recommended expenses were 

reasonable and necessary to adequately 

cover program operations. Prior to 

arriving at its budget of $46,497, the 

Committee considered information from 

various sources, including the 

Committee’s Executive Subcommittee. 

The Executive Subcommittee reviewed 

the administrative expenses shared 

between the Committee and the CDPB 

in recent years. 

According to NASS, the season 

average producer price was $1,230 in 

2009 and $1,180 per ton of salable dried 

prunes in 2010. A review of this 

historical data and preliminary 

information pertaining to the upcoming 

crop year indicates that the producer 

prices for the 2011–12 crop year could 

range between $1,230 and $1,180. 

Therefore, the estimated assessment 

revenue for the 2011–12 crop year as a 

percentage of total producer prices 

during the 2011–12 crop year could 

range between 0.018 and 0.019 percent. 

This action decreases the assessment 

obligation imposed on handlers. 

Assessments are applied uniformly on 

all handlers, and some of the costs may 

be passed on to producers. However, 

decreasing the assessment rate reduces 

the burden on handlers, and may reduce 

the burden on producers. In addition, 

the Committee’s meeting was widely 

publicized throughout the California 

dried prune industry and all interested 

persons were invited to attend the 

meeting and participate in Committee 

deliberations on all issues. Like all 

Committee meetings, the June 16, 2011, 

meeting was a public meeting and all 

entities, both large and small, were able 

to express views on this issue. Finally, 

interested persons are invited to submit 

comments on this interim rule, 

including the regulatory and 

informational impacts of this action on 

small businesses. 

In accordance with the Paperwork 

Reduction Act of 1995, (44 U.S.C. 

Chapter 35), the order’s information 

collection requirements have been 

previously approved by the Office of 

Management and Budget (OMB) and 

assigned OMB No. 0581–0178 Vegetable 

and Specialty Crop Marketing Orders. 

No changes in those requirements as a 

result of this action are necessary. 

Should any changes become necessary, 

they would be submitted to OMB for 

approval. 

This action imposes no additional 

reporting or recordkeeping requirements 

on either small or large California dried 

prune handlers. As with all Federal 

marketing order programs, reports and 

forms are periodically reviewed to 

reduce information requirements and 

duplication by industry and public 

sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this rule. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

MarketingOrdersSmallBusinessGuide. 

Any questions about the compliance 

guide should be sent to Laurel May at 

the previously mentioned address in the 

FOR FURTHER INFORMATION CONTACT

section. 

After consideration of all relevant 

material presented, including the 

information and recommendation 

submitted by the Committee and other 

available information, it is hereby found 

that this rule, as hereinafter set forth, 

will tend to effectuate the declared 

policy of the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect, and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) The 2011–12 crop year 

begins on August 1, 2011, and the 

marketing order requires that the rate of 

assessment for each crop year apply to 

all assessable dried prunes handled 

during such crop year; (2) this action 

decreases the assessment rate for 

assessable dried prunes beginning with 


srobinson on DSK4SPTVN1PROD with RULES
53816 Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Rules and Regulations 

the 2011–12 crop year; (3) handlers are 

aware of this action which was 

unanimously recommended by the 

Committee at a public meeting and is 

similar to other assessment rate actions 

issued in past years; and (4) this interim 

rule provides a 60-day comment period, 

and all comments timely received will 

be considered prior to finalization of 

this rule. 

List of Subjects in 7 CFR Part 993 

Marketing agreements, Plums, Prunes, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, 7 CFR part 993 is amended as 

follows: 

PART 993—DRIED PRUNES 

PRODUCED IN CALIFORNIA 

■ 1. The authority citation for 7 CFR 

part 993 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Section 993.347 is revised to read 

as follows: 

§ 993.347 Assessment rate. 

On and after August 1, 2011, an 

assessment rate of $0.22 per ton is 

established for California dried prunes. 

Dated: August 19, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–22119 Filed 8–29–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 1217 

[Document Number AMS–FV–10–0015C; 

FR] 

RIN 0581–AD03 

Softwood Lumber Research, 

Promotion, Consumer Education and 

Industry Information Order; Correction 

AGENCY: Agricultural Marketing Service. 

ACTION: Corrections to final rule. 

SUMMARY: This document contains 

corrections to the final rule published 

on August 2, 2011 (76 FR 46185), 

regarding softwood lumber. Corrections 

are made in the amendatory instruction 

section and in § 1217.88 of the final 

rule. 

DATES: Effective Date: August 31, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Maureen T. Pello, Marketing Specialist, 

Research and Promotion Division, Fruit 

and Vegetable Programs, AMS, USDA, 

P.O. Box 831, Beavercreek, Oregon 

97004; telephone: (503) 632–8848; 

facsimile (503) 632–8852; or electronic 

mail: Maureen.Pello@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

This rule establishes a Softwood 

Lumber Research, Promotion, Consumer 

Education and Industry Information 

Order (Order). The purpose of the Order 

is to strengthen the position of softwood 

lumber in the marketplace, maintain 

and expand markets for softwood 

lumber, and develop new uses for 

softwood lumber within the United 

States. The Order is issued pursuant to 

the Commodity Promotion, Research, 

and Information Act of 1996 (7 U.S.C. 

7411–7425). 

Corrections 

In FR Doc. 2011–19491, published 

August 2, 2011 (76 FR 46185), make the 

following corrections. 

1. On page 46193, in column 2, the 

words of issuance are corrected to read 

as follows: 

For the reasons set forth in the 

preamble, Title 7, Chapter XI of the 

Code of Federal Regulations is amended 

by adding subpart A to part 1217 to read 

as follows: 

2. On page 46194, column 1, the 

words ‘‘Subpart B—[Reserved]’’ are 

removed. 

3. On page 46202 in column 1, 

§ 1217.88 is revised to read as follows: 

§ 1217.88 OMB Control numbers. 

The control numbers assigned to the 

information collection requirements by 

the Office of Management and Budget 

pursuant to the Paperwork Reduction 

Act of 1995, 44 U.S.C. Chapter 35, are 

OMB control number 0505–0001 (Board 

nominee background statement) and 

OMB control number 0581–0264. 

Dated: August 22, 2011. 

David R. Shipman, 

Acting Administrator. 

[FR Doc. 2011–22150 Filed 8–29–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2011–N–0002] 

Advisory Committee; Change of Name 

and Function; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

standing advisory committees’ 

regulations to change the name and 

function of the Anesthetic and Life 

Support Drugs Advisory Committee. 

This action is being taken to reflect 

changes made to the charter for this 

advisory committee. 

DATES: Effective September 6, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Philip Bautista, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing that the name of the 

Anesthetic and Life Support Drugs 

Advisory Committee, which was 

established on May 1, 1978, has been 

changed. The Agency decided that the 

name ‘‘Anesthetic and Analgesic Drug 

Products Advisory Committee’’ would 

more accurately describe the subject 

areas for which the committee is 

responsible. The mandate of the 

committee is being expanded to include 

analgesics, e.g., abuse-deterrent opioids, 

novel analgesics, and opioid abuse. 

The Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products 

including analgesics, e.g., abusedeterrent opioids, novel analgesics, and 

issues related to opioid abuse, and those 

for use in anesthesiology. 

The Anesthetic and Life Support 

Drugs Advisory Committee name was 

changed and its functions expanded in 

the charter renewal dated June 9, 2011. 

FDA is hereby revising 21 CFR 14.100 

(c)(1) to reflect these changes. 

Publication of this final rule 

constitutes a final action on this change 

under the Administrative Procedure 

Act. Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the Agency 

finds good cause to dispense with notice 

and public procedure and to proceed to 

an immediately effective regulation. 

Such notice and procedures are 

unnecessary and are not in the public 

interest, because the final rule is merely 

codifying the new name and the 

expanded function of the advisory 

committee to reflect the current 

committee charter. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

Therefore, under the Federal Food 

and Drug, and Cosmetic Act and under 


srobinson on DSK4SPTVN1PROD with RULES