Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations 4081

Federal Aviation Regulations (14 CFR

part 97) is amended by establishing,

amending, suspending, or revoking

Standard Instrument Approach

Procedures, effective at 0901 UTC on

the dates specified, as follows:

PART 97—STANDARD INSTRUMENT

APPROACH PROCEDURES

1. The authority citation for part 97

continues to read as follows:

Authority: 49 U.S.C. app. 1348, 1354(a),

1421 and 1510; 49 U.S.C. 106(g); and 14 CFR

11.49(b)(2).

2. Part 97 is amended to read as

follows:

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended]

By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, AND VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA,

LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV; § 97.31

RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, identified as follows:

* * * Effective Upon Publication

FDC Date State City Airport FDC Number SIAP

12/15/94 .......... GA .... Cartersville ................... Cartersville .................................... FDC 4/6963 .................. NDB or GPS Rwy 19 Amdt

3.

12/15/94 .......... GA .... Cartersville ................... Cartersville .................................... FDC 4/6964 .................. LOC Rwy 19 Amdt 1.

12/15/94 .......... NC .... Statesville ..................... Statesville Muni ............................ FDC 4/6972 .................. VOR/DME Rwy 10, Amdt 6.

12/15/94 .......... NC .... Statesville ..................... Statesville Muni ............................ FDC 4/6973 .................. NDB Rwy 20 Amdt 8.

12/15/94 .......... SC .... Winnsboro .................... Fairfield County ............................ FDC 4/6965 .................. NDB or GPS Rwy 4 Amdt

3.

12/16/94 .......... IL ...... Moline ........................... Quad-City Airport .......................... FDC 4/6987 .................. ILS Rwy 9 Amdt 29.

12/16/94 .......... IL ...... Moline ........................... Quad-City Airport .......................... FDC 4/6988 .................. ILS Rwy 27 Orig.

12/16/94 .......... IL ...... Springfield .................... Springfield Capital ........................ FDC 4/6984 .................. Radar-1 Amdt 7A.

12/19/94 .......... NM .... Albuquerque ................. Double Eagle II ............................. FDC 4/7009 .................. ILS Rwy 22 Amdt 1.

12/20/94 .......... ND .... Jamestown ................... Jamestown Muni .......................... FDC 4/7028 .................. ILS Rwy 31 Amdt 7.

12/21/94 .......... SC .... Lake City ...................... Lake City Muni/CJ Evans Field .... FDC 4/7041 .................. NDB or GPS–A, Amdt 1.

12/23/94 .......... NC .... Siler City ....................... Siler City Muni .............................. FDC 4/7061 .................. NDB Rwy 21 Orig.

12/23/94 .......... NC .... Siler City ....................... Siler City Muni .............................. FDC 4/7066 .................. VOR–A Amdt 1.

[FR Doc. 95–948 Filed 1–19–95; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

National Institute of Standards and

Technology

15 CFR Part 291

[Docket No. 941097–4363]

RIN 0693–AB36

Manufacturing Extension Partnership;

Environmental Projects

AGENCY: National Institute of Standards

and Technology, Commerce.

ACTION: Final rule.

SUMMARY: The purpose of this rule is to

provide for integration of environmental

services and resources into the national

manufacturing extension system and to

codify the process by which NIST will

solicit and select applications for

cooperative agreements and financial

assistance on projects which have the

dual benefit of promoting the

competitiveness and environmental

soundness of smaller U.S.

manufacturers. The intended effect is to

increase the scope and scale of

environmental services provided

through the national manufacturing

extension system.

EFFECTIVE DATE: January 20, 1995.

ADDRESSES: Applicants must submit one

signed original plus six copies of the

proposal along with Standard Form 424,

424A (Rev 4–92) prescribed by the

applicable OMB circular and Form CD–

511, Certification Regarding Debarment,

Suspension and Other Responsibility

Matters; Drug-Free Workplace

Requirements and Lobbying. SF–424,

424A (Rev 4–92) and Form CD–511 will

not be considered part of the page count

of the Basic Proposal. Proposals must be

submitted to: MEP Environmental

Projects, Attention Environmental

Projects Manager, National Institute of

Standards and Technology Bldg. 224

Room B115, Gaithersburg, MD 20899–

0001.

FOR FURTHER INFORMATION CONTACT: The

Manufacturing Extension Partnership

Environmental Projects Manager, 301–

975–5020.

SUPPLEMENTARY INFORMATION: In the

November 14, 1994 Federal Register,

Volume 59, No. 218, 59 FR 56439, the

National Institute of Standards and

Technology published a notice of

proposed rulemaking to add 15 CFR part

291 to provide for the integration of

environmental services and resources

into the national manufacturing

extension system and to codify the

process by which NIST will solicit and

select applications for cooperative

agreements and financial assistance on

projects which have the dual benefit of

promoting the competitiveness and

environmental soundness of smaller

U.S. manufacturers. No comments on

the rules were received. These final

rules are the same as the proposed rules

with the addition of section 291.6 which

clarifies the additional requirements to

which recipients and subrecipients are

subject.

The purpose of the National Institute

of Standards and Technology

Manufacturing Extension Partnership is

to promote the competitiveness of

smaller U.S. manufacturers. This is

done primarily through technical

assistance provided by a network of

nonprofit manufacturing extension

centers. The purpose of this rule is to

provide for the integration of

environmental services and resources

into the national manufacturing

extension system and to codify the

process by which NIST will solicit and

select applications for cooperative

agreements and financial assistance on

projects which have the dual benefit of

promoting the competitiveness and

environmental soundness of smaller

U.S. manufacturers. Proposals from

qualified organizations will periodically

be solicited for projects which

accomplish any one of the following

objectives:

Integration of Environmental Services Into

Manufacturing Extension Centers: to support

the integration of environmentally-focused

technical assistance, and especially pollution

prevention assistance, for smaller

manufacturers into the broader services

4082 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations

provided by manufacturing extension

centers.

Development of Environmentally Related

Technical Assistance Tools and Techniques:

to support the initial development and

implementation of tools or techniques which

will aide manufacturing extension

organizations in providing environmentallyrelated services, and especially pollution

prevention services, to smaller manufacturers

and which also may be of direct use by the

smaller manufacturers themselves. Specific

industry sectors and categories of tools and

techniques may be specified in solicitations.

Pilots for National Industry-Specific

Pollution Prevention and Environmental

Compliance Information Centers: to support

the pilot implementation of national centers

for specific industry sectors specified in

solicitations. The centers will provide easy

access to relevant, current, reliable and

comprehensive information on innovative

technologies, pollution prevention

opportunities and regulatory compliance.

Integration projects are open to

existing manufacturing extension

affiliates of the NIST Manufacturing

Extension Partnership.

Projects for development of tools or

techniques and national information

centers are open to all nonprofit

organizations including universities,

community colleges, state governments,

and independent nonprofit

organizations.

Announcements of solicitations will

be made in the Commerce Business

Daily.

In accordance with the provisions of

the National Institute of Standards and

Technology Act (15 U.S.C. 272(b)(1) and

(c)(3) and 2781), as amended, NIST will

provide assistance to integrate

environmentally-related services and

resources into the national

manufacturing extension system. This

assistance will be provided by NIST

often in cooperation with other federal

agencies such as the EPA. Under the

NIST Manufacturing Extension

Partnership (MEP), NIST will

periodically make merit-based awards to

existing MEP manufacturing extension

affiliates for integration of

environmental services into extension

centers and to non-profit organizations

for development of environmentallyrelated tools and techniques. In

addition, NIST will initiate pilot centers

providing environmental information

for specific industrial sectors to be

specified in solicitations. MEP assumes

a broad definition of manufacturing, and

recognizes a wide range of technology

and concepts, including durable goods

production; chemical, biotechnology,

and other materials processing;

electronic component and system

fabrication; and engineering services

associated with manufacturing, as lying

within the definition of manufacturing.

Classification

This notice relating to public

property, loans, grants, benefits, or

contracts is exempt from all

requirements of section 553 of the

Administrative Procedure Act (5 U.S.C.

553(a)(2)) including notice and

opportunity for comment. Therefore, a

Regulatory Flexibility Analysis is not

required and was not prepared for this

notice for purposes of the Regulatory

Flexibility Act (5 U.S.C. 603 and 604).

The program is not a major Federal

action requiring an environmental

assessment under the National

Environmental Policy Act. This notice

does not contain policies with

Federalism implications sufficient to

warrant preparation of a Federalism

assessment under Executive Order

12612. This notice contains collection of

information requirements subject to the

Paperwork Reduction Act which have

been approved by the Office of

Management and Budget (OMB Control

Number 0693–0010, 0348–0043 and

0348–0044). Public reporting burden for

this collection of information is

estimated to average 40 hours per

response, including the time for

reviewing instructions, searching

existing data sources, gathering the data

needed, and completing and reviewing

the collection of information. Send

comments regarding this burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden, to

the address shown above; and to the

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Washington, D.C. 20503.

It has been determined that this rule

is not significant for purposes of EO

12866.

List of Subjects in 15 CFR Part 291

Environmental projects,

Environmental compliance assistance,

Manufacturing extension, Pollution

prevention assistance, Technical

assistance.

Dated: January 13, 1995.

Samuel Kramer,

Associate Director.

For the reasons set out in the

preamble, 15 CFR part 291 is added as

set forth below.

PART 291—MANUFACTURING

EXTENSION PARTNERSHIP;

ENVIRONMENTAL PROJECTS

Sec.

291.1 Program description.

291.2 Environmental integration projects.

291.3 Environmental tools and techniques

projects.

291.4 National industry-specific pollution

prevention and environmental

compliance resource centers.

291.5 Proposal selection process.

291.6 Additional requirements.

Authority: 15 U.S.C. § 272(b)(1) and (c)(3)

and § 2781.

§ 291.1 Program description.

(a) In accordance with the provisions

of the National Institute of Standards

and Technology Act (15 U.S.C.

§ 272(b)(1) and (c)(3) and § 2781), as

amended, NIST will provide financial

assistance to integrate environmentallyrelated services and resources into the

national manufacturing extension

system. This assistance will be provided

by NIST often in cooperation with the

EPA. Under the NIST Manufacturing

Extension Partnership (MEP), NIST will

periodically make merit-based awards to

existing MEP manufacturing extension

affiliates for integration of

environmental services into extension

centers and to non-profit organizations

for development of environmentallyrelated tools and techniques. In

addition, NIST will initiate pilot centers

providing environmental information

for specific industrial sectors to be

specified in solicitations. MEP assumes

a broad definition of manufacturing, and

recognizes a wide range of technology

and concepts, including durable goods

production; chemical, biotechnology,

and other materials processing;

electronic component and system

fabrication; and engineering services

associated with manufacturing, as lying

within the definition of manufacturing.

(b) Announcements of solicitations.

Announcements of solicitations will be

made in the Commerce Business Daily.

Specific information on the level of

funding available and the deadline for

proposals will be contained in that

announcement. In addition, any specific

industry sectors or types of tools and

techniques to be focused on will be

specified in the announcement.

(c) Proposal workshops. Prior to an

announcement of solicitation, NIST may

announce opportunities for potential

applicants to learn about these projects

through workshops. The time and place

of the workshop(s) will be contained in

a Commerce Business Daily

announcement.

(d) Indirect costs. The total dollar

amount of the indirect costs proposed in

an application under this program must

not exceed the indirect cost rate

negotiated and approved by a cognizant

Federal agency prior to the proposed

effective date of the award or 100

percent of the total proposed direct

costs dollar amount in the application,

whichever is less.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations 4083

(e) Proposal format. The Proposal

must not exceed 20 typewritten pages in

length for integration proposals.

Proposals for tools and techniques

projects and national information

centers must not exceed 30 pages in

length. The proposal must contain both

technical and cost information. The

Proposal page count shall include every

page, including pages that contain

words, table of contents, executive

summary, management information and

qualifications, resumes, figures, tables,

and pictures. All proposals shall be

printed such that pages are single-sided,

with no more than fifty-five (55) lines

per page. Use 21.6 x 27.9 cm (81⁄2′′ x

11′′) paper or A4 metric paper. Use an

easy-to-read font of not more than about

5 characters per cm (fixed pitch font of

12 or fewer characters per inch or

proportional font of point size 10 or

larger). Smaller type may be used in

figures and tables, but must be clearly

legible. Margins on all sides (top,

bottom, left and right) must be at least

2.5 cm. (1′′). The applicant may submit

a separately bound document of

appendices, containing letters of

support for the Basic Proposal. The

basic proposal should be self-contained

and not rely on the appendices for

meeting criteria. Excess pages in the

Proposal will not be considered in the

evaluation. Applicants must submit one

signed original plus six copies of the

proposal along with Standard Form 424,

424A (Rev 4/92) and Form CD–511.

(f) Content of basic proposal. The

Basic Proposal must, at a minimum,

include the following:

(1) An executive summary

summarizing the planned project

consistent with the Evaluation Criteria

stated in this notice.

(2) A description of the planned

project sufficient to permit evaluation of

the proposal in accordance with the

proposal Evaluation Criteria stated in

this notice.

(3) A budget for the project which

identifies all sources of funds and

which breaks out planned expenditures

by both activity and object class (e.g.,

personnel, travel, etc.).

(4) A description of the qualifications

of key personnel who will be assigned

to work on the proposed project.

(5) A statement of work that discusses

the specific tasks to be carried out,

including a schedule of measurable

events and milestones.

(6) A Standard Form 424, 424A (Rev

4–92) prescribed by the applicable OMB

circular and Form CD–511, Certification

Regarding Debarment, Suspension and

Other Responsibility Matters; Drug-Free

Workplace Requirements and Lobbying.

SF–424, 424A (Rev 4–92) and Form CD–

511 will not be considered part of the

page count of the Basic Proposal.

(7) The application requirements and

the standard form requirements have

been approved by OMB (OMB Control

Number 0693–0010, 0348–0043 and

0348–0044).

(g) Applicable federal and

departmental guidance. This includes:

Administrative Requirements, Cost

Principles, and Audits. [Dependent

upon type of Recipient organization:

nonprofit, for-profit, state/local

government, or educational institution]

(1) Nonprofit organizations.

(i) OMB Circular A–110—Uniform

Administrative Requirements of Grants

and Agreements with Institutions of

Higher Education, Hospitals, and Other

Nonprofit Organizations.

(ii) OMB Circular A–122—Cost

Principles for Nonprofit Organizations.

(iii) 15 CFR part 29b—Audit

Requirements for Institutions of Higher

Education and Other Nonprofit

Organizations [implements OMB

Circular A–133—Audits for Institutions

of Higher Education and Other

Nonprofit Organizations].

(2) State/local governments.

(i) 15 CFR part 24—Uniform

Administrative Requirements for Grants

and Cooperative Agreements to State

and Local Governments.

(ii) OMB Circular A–87—Cost

Principles for State and Local

Governments.

(iii) 15 CFR part 29a—Audit

Requirements for State and Local

Governments [implements OMB

Circular A–128—Audit of State and

Local Governments].

(3) Educational institutions

(i) OMB Circular A–110—

Administrative Requirements for Grants

and Agreements with Institutions of

Higher Education, Hospitals, and Other

Nonprofit Organizations.

(ii) OMB Circular A–21—Cost

Principles for Educational Institutions.

(iii) 15 CFR part 29b—Audit

Requirements for Institutions of Higher

Education and Other Nonprofit

Organizations [implements OMB

Circular A–133—Audits for Institutions

of Higher Education and Other

Nonprofit Organizations].

§ 291.2 Environmental integration

projects.

(a) Eligibility criteria. Eligible

applicants for these projects are

manufacturing extension centers or state

technology extension programs which at

the time of solicitation have grants,

cooperative agreements or contracts

with the NIST Manufacturing Extension

Partnership. Only one proposal per

organization per solicitation is

permitted in this category.

(b) Project objective. The purpose of

these projects is to support the

integration of environmentally-focused

technical assistance, and especially

pollution prevention assistance, for

smaller manufacturers into the broader

services provided by existing MEP

manufacturing extension centers.

Proposers are free to structure their

project in whatever way will be most

effective and efficient in increasing the

ability of the center to deliver high

quality environmental and pollution

prevention technical assistance (either

directly or in partnership with other

organizations). Following are some

examples of purposes for which these

funds could be used. This list is by no

means meant to be all inclusive. A

center might propose a set of actions

encompassing several of these examples

as well as others.

(1) Environmental needs assessment.

Detailed assessment of the

environmentally-related technical

assistance needs of manufacturers

within the state or region of the

manufacturing extension center. This

would be done as part of a broader plan

to incorporate environmentally related

services into the services of the

manufacturing extension center. The

center might propose to document its

process and findings so that other

centers may learn from its work.

(2) Partnership with another

organization. The center might propose

to partner with an existing organization

which is providing environmentallyfocused technical assistance to

manufacturers. The partnership would

lead to greater integration of service

delivery through joint technical

assistance projects and joint training.

(3) Accessing private-sector

environmental resources. The center

might propose to increase it’s ability to

access environmental technical services

for smaller manufacturers from

environmental consultants or

environmental firms.

(4) Training of field engineers/agents

in environmental topics. Funding for

training which empowers the field

engineer/agent with the knowledge

needed to recognize potential

environmental, and especially pollution

prevention, problems and opportunities.

In addition, training might be funded

which empowers the field engineer/

agent with the knowledge needed to

make appropriate recommendations for

solutions or appropriate referrals to

other sources of information or

expertise. The over-arching goal is for

the field engineer/agent to enable the

manufacturer to be both

environmentally clean and competitive.

4084 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations

(5) Access to environmentally related

information or expertise. A center might

propose to fund access to databases or

other sources of environmentally-related

information or expertise which might be

necessary to augment the

environmentally focused activities of

the manufacturing extension center.

(6) Addition of environmentally

focused staff. It may be necessary for

manufacturing extension centers to have

an environmental program manager or

lead field engineer/agent with

environmental training and experience.

Funds could be requested to hire this

person. However, the proposer would

have to demonstrate a clear and

reasonable plan for providing for the

support of this person after the funds

provided under this project are

exhausted since no commitment is

being made to on-going funding.

(c) Award period. Projects initiated

under this category may be carried out

over multiple years. The proposer

should include optional second and

third years in their proposal. Proposals

selected for award may receive one, two

or three years of funding from currently

available funds at the discretion of DOC.

If an application is selected for funding,

DOC has no obligation to provide any

additional future funding in connection

with that award. A separate cooperative

agreement will be written with winning

applicants. Renewal of an award to

increase funding or extend the period of

performance is at the total discretion of

DOC. It is anticipated that successful

projects will be given the opportunity to

roll the funding for these efforts into the

base funding for the extension center.

Such a roll-over will be based on a

performance review and the availability

of funds.

(d) Matching requirements. No

matching funds are required for these

proposals. However, the presence of

matching funds (cash and in-kind) will

be considered in the evaluation under

the Financial Plan criteria.

(e) Environmental integration projects

evaluation criteria. In most solicitations,

preference will be given to projects

which are focused on a single industry

sector. This is desired to build on the

expertise and resources which are being

built in tools and resources projects in

these industry sectors. Industry focus

will be specified in the solicitation

announcement. However, actual

services need not be limited exclusively

to this sector. In addition preference

may be given to extension centers which

do not have extensive environmentallyrelated services already in place. In

addition to these preferences, the

criteria for selection of awards will be

as follows in descending order of

importance:

(1) Demonstrated commitment to

incorporating environmentally related

services. The extension center must

demonstrate its commitment to

incorporate environmentally-related

technical services into its overall

manufacturing extension services even

after funding for this project is

exhausted. It is not the objective of this

effort to establish completely

autonomous environmentally focused

extension centers. Rather, the goal is to

ensure that such services are integrated

directly with general manufacturing

extension services focused on

competitiveness. The center must

demonstrate that such integration will

take place. Factors that may be

considered include: The amount of

matching funds devoted to the efforts

proposed as demonstration of the

center’s commitment to the activity;

indication that environmental services

are a significant aspect of the

organization’s long range planning;

strength of commitment and plans for

continuing service beyond funding

which might be awarded through this

project; the degree to which

environmental services will become an

integral part of each field engineers’

portfolio of services; the level of current

or planned education and training of

staff on relevant environmental issues;

and the extent of environmentally

related information and expert resources

which will be easily accessible by field

engineers.

(2) Demonstrated understanding of

the environmentally related technical

assistance needs of manufacturers in

the target population. Target population

must be clearly defined. The

manufacturing center must demonstrate

that it understands the populations

environmentally related needs or

include a coherent methodology for

identifying those needs. The proposal

should show that the efforts being

proposed will enable the center to better

meet those needs. Factors that may be

considered include: A clear definition of

the target population, its size and

demographic characteristics;

demonstrated understanding of the

target population’s environmental

technical assistance needs or a plan to

develop this understanding; and

appropriateness of the size of the target

population and the anticipated impact

for the proposed expenditure.

(3) Coordination with other relevant

organizations. Wherever possible the

project should be coordinated with and

leverage other organizations which are

providing high quality environmentallyrelated services to manufacturers in the

same target population or which have

relevant resources which can be of

assistance in the proposed effort. If no

such organizations exist, the proposal

should build the case that there are no

such organizations. Applicants will

need to describe how they will

coordinate to allow for increased

economies of scale and to avoid

duplication of services in providing

assistance to small and medium-sized

manufacturers. Factors that may be

considered include: Demonstrated

understanding of existing organizations

and resources relevant for providing

technology assistance related services to

the target population; adequate linkages

and partnerships with existing

organizations and clear definition of

those organizations’ roles in the

proposed activities; and that the

proposed activity does not duplicate

existing services or resources.

(4) Program evaluation: The applicant

should specify plans for evaluation of

the effectiveness of the proposed

program and for ensuring continuous

improvement of program activities.

Factors that may be considered include:

Thoroughness of evaluation plans,

including internal evaluation for

management control, external

evaluation for assessing outcomes of the

activity, and ‘‘customer satisfaction’’

measures of performance.

(5) Management experience and

plans. Applicants should specify plans

for proper organization, staffing, and

management of the implementation

process. Factors that may be considered

include: Appropriateness and authority

of the governing or managing

organization to conduct the proposed

activities; qualifications of the project

team and its leadership to conduct the

proposed activity; soundness of any

staffing plans, including recruitment,

selection, training, and continuing

professional development;

appropriateness of the organizational

approach for carrying out the proposed

activity; evidence of involvement and

support by private industry.

(6) Financial plan: Applicants should

show the relevance and cost

effectiveness of the financial plan for

meeting the objectives of the project; the

firmness and level of the applicant’s

total financial support for the project;

and a plan to maintain the program after

the cooperative agreement has expired.

Factors that may be considered include:

Reasonableness of the budget both in

income and expenses; strength of

commitment and amount of the

proposer’s cost share, if any;

effectiveness of management plans for

control of budget; appropriateness of

matching contributions; and plans for

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations 4085

maintaining the program after the

cooperative agreement has expired.

§ 291.3 Environmental tools and

techniques projects.

(a) Eligibility criteria. Eligible

applicants for these projects include all

nonprofit organizations including

universities, community colleges, state

governments, state technology programs

and independent nonprofit

organizations. Organizations may

submit multiple proposals under this

category in each solicitation for unique

projects.

(b) Project objective. The purpose of

these projects is to support the initial

development and implementation of

tools or techniques which will aide

manufacturing extension organizations

in providing environmentally-related

services to smaller manufacturers and

which may also be of direct use by the

smaller manufacturers themselves.

Specific industry sectors to be

addressed and sub-categories of tools

and techniques may be specified in

solicitations. These sectors or subcategories will be specified in the

solicitation announcement. Examples of

tools and techniques include, but are

not limited to, manufacturing

assessment tools, environmental

benchmarking tools, training delivery

programs, electronically accessible

environmental information resources,

environmental demonstration facilities,

software tools, etc. Projects must be

completed within the scope of the effort

proposed and should not require ongoing federal support.

(c) Award period. Projects initiated

under this category may be carried out

over up to three years. Proposals

selected for award will receive all

funding from currently available funds.

If an application is selected for funding,

DOC has no obligation to provide any

additional future funding in connection

with that award. Renewal of an award

to increase funding or extend the period

of performance is at the total discretion

of DOC.

(d) Matching requirements. No

matching funds are required for these

proposals. However, the presence of

matching funds (cash and in-kind) will

be considered in the evaluation under

the Financial Plan criteria.

(e) Environmental tools and

techniques projects evaluation criteria.

Proposals from applicants will be

evaluated and rated on the basis of the

following criteria listed in descending

order of importance:

(1) Demonstrated understanding of

the environmentally-related technical

assistance needs of manufacturers and

technical assistance providers in the

target population. Target population

must be clearly defined. The proposal

must demonstrate that it understands

the population’s environmentally

related tool or technique needs. The

proposal should show that the efforts

being proposed meet the needs

identified. Factors that may be

considered include: A clear definition of

the target population, size and

demographic distribution; demonstrated

understanding of the target population’s

environmental tools or techniques

needs; and appropriateness of the size of

the target population and the

anticipated impact for the proposed

expenditure.

(2) Technology and information

sources. The proposal must delineate

the sources of technology and/or

information which will be used to create

the tool or resource. Sources may

include those internal to the center

(including staff expertise) or from other

organizations. Factors that may be

considered include: Strength of core

competency in the proposed area of

activity; and demonstrated access to

relevant technical or information

sources external to the organization.

(3) Degree of integration with the

manufacturing extension partnership.

The proposal must demonstrate that the

tool or resource will be integrated into

and will be of service to the NIST

Manufacturing Extension Centers.

Factors that may be considered include:

Ability to access the tool or resource

especially for MEP extension centers;

methodology for disseminating or

promoting use of the tool or technique

especially within the MEP system; and

demonstrated interest in using the tool

or technique especially by MEP

extension centers.

(4) Coordination with other relevant

organizations. Wherever possible the

project should be coordinated with and

leverage other organizations which are

developing or have expertise on similar

tools or techniques. If no such

organizations exist, the proposal should

show that this the case. Applicants will

need to describe how they will

coordinate to allow for increased

economies of scale and to avoid

duplication. Factors that may be

considered include: Demonstrated

understanding of existing organizations

and resources relevant to the proposed

project; Adequate linkages and

partnerships with existing organizations

and clear definition of those

organizations’ roles in the proposed

activities; and that the proposed activity

does not duplicate existing services or

resources.

(5) Program evaluation. The applicant

should specify plans for evaluation of

the effectiveness of the proposed tool or

technique and for ensuring continuous

improvement of the tool. Factors that

may be considered include:

Thoroughness of evaluation plans,

including internal evaluation for

management control, external

evaluation for assessing outcomes of the

activity, and ‘‘customer satisfaction’’

measures of performance.

(6) Management experience and

plans. Applicants should specify plans

for proper organization, staffing, and

management of the implementation

process. Factors that may be considered

include: Appropriateness and authority

of the governing or managing

organization to conduct the proposed

activities; qualifications of the project

team and its leadership to conduct the

proposed activity; soundness of any

staffing plans, including recruitment,

selection, training, and continuing

professional development; and

appropriateness of the organizational

approach for carrying out the proposed

activity.

(7) Financial plan: Applicants should

show the relevance and cost

effectiveness of the financial plan for

meeting the objectives of the project; the

firmness and level of the applicant’s

total financial support for the project;

and a plan to maintain the program after

the cooperative agreement has expired.

Factors that may be considerable

include: Reasonableness of the budget,

both in income and expenses; strength

of commitment and amount of the

proposers’s cost share, if any;

effectiveness of management plans for

control of budget appropriateness of

matching contributions; and plan for

maintaining the program after the

cooperative agreement has expired.

§ 291.4 National industry-specific pollution

prevention and environmental compliance

resource centers.

(a) Eligibility criteria. Eligible

applicants for these projects include all

nonprofit organizations including

universities, community colleges, state

governments, state technology programs

and independent nonprofit

organizations. Only one proposal per

organization is permitted in this

category.

(b) Project objective. These centers

will provide easy access to relevant,

current, reliable and comprehensive

information on pollution prevention

opportunities, regulatory compliance

and technologies and techniques for

reducing pollution in the most

competitive manner for a specific

industry sector or industrial process.

The sector or industrial process to be

addressed will be specified in the

4086 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations

solicitation. The center will enhance the

ability of small businesses to implement

risk based pollution prevention

alternatives to increase competitiveness

and reduce adverse environmental

impacts. The center should use existing

resources, information and expertise

and will avoid duplication of existing

efforts. The information provided by the

center will create links between relevant

EPA Pollution Prevention programs,

EPA and other technical information,

NIST manufacturing extension efforts,

EPA regulation and guidance, and state

requirements. The center will

emphasize pollution prevention

methods as the principal means to both

comply with government regulations

and enhance competitiveness.

(c) Project goal. To improve the

environmental and competitive

performance of smaller manufacturers

by:

(1) Enhancing the national capability

to provide pollution prevention and

regulatory requirements information

(federal, state and local) to specific

industries.

(2) Providing easy access to relevant

and reliable information and tools on

pollution prevention technologies and

techniques that achieve manufacturing

efficiency and enhanced

competitiveness with reduced

environmental impact.

(3) Providing easy access to relevant

and reliable information and tools to

enable specific industries to achieve the

continued environmental improvement

to meet or exceed compliance

requirements.

(d) Project customers. (1) The

customers for this center will be the

businesses in the industrial sector or

businesses which use the industrial

process specified as the focus for the

solicitation. In addition, consultants

providing services to those businesses,

the NIST Manufacturing Extension

Centers, and federal state and local

programs providing technical, pollution

prevention and compliance assistance.

(2) The center should assist the

customer in choosing the most costeffective, environmentally sound

options or practices that enhance the

company’s competitiveness. Assistance

must be accessible to all interested

customers. The center, wherever

feasible, shall use existing materials and

information to enhance and develop the

services to its customers. The centers

should rarely, if ever, perform research,

but should find and assimilate data and

information produced by other sources.

The center should not duplicate any

existing distribution system. The center

should distribute and provide

information, but should not directly

provide on-site assistance to customers.

Rather, referrals to local technical

assistance organizations should be given

when appropriate. Information would

likely be available through multiple

avenues such as phone, fax,

electronically accessible data bases,

printed material, networks of technical

experts, etc.

(e) Award period. The pilot initiated

under this category may be carried out

over multiple years. The proposers

should include optional second and

third years in their proposal. Proposals

selected for award may receive one, two

or three years of funding from currently

available finds at the discretion of DOC.

If an application is selected for funding,

DOC has no obligation to provide any

additional future funding in connection

with that award. Renewal of an award

to increase funding or extend the period

of performance is at the total discretion

of DOC. Successful centers may be given

an opportunity to receive continuing

funding as a NIST manufacturing center

after the expiration of their initial

cooperative agreement. Such a roll-over

will be based upon the performance of

the center and availability of funding.

(f) Matching requirements. A

matching contribution from each

applicant will be required. NIST may

provide financial support up to 50% of

the total budget for the project. The

applicant’s share of the budget may

include dollar contributions from state,

county, industrial or other non-federal

sources and non-federal in-kind

contributions necessary and reasonable

for proper accomplishment of project

objectives.

(g) Resource center evaluation

criteria. Proposals from applicants will

be evaluated and rated on the basis of

the following criteria listed in

descending order of importance:

(1) Demonstrated understanding of

the environmentally-related information

needs of manufacturers and technical

assistance providers in the target

population. Understanding the

environmentally-related needs of the

target population (i.e., customers) is

absolutely critical to the success of such

a resource center. Factors that may be

considered include: A clear definition of

the target population, size and

demographic distribution; demonstrated

understanding of the target population’s

environmentally-related information

needs or a clear plan for identifying

those customer needs; and

methodologies for continually

improving the understanding of the

target population’s environmentallyrelated information needs.

(2) Delivery mechanisms. The

proposal must set forth clearly defined,

effective mechanisms for delivery of

services to target population. Factors

that may be considered include:

Potential effectiveness and efficiency of

proposed delivery systems; and

demonstrated capacity to form the

effective linkages and partnerships

necessary for success of the proposed

activity.

(3) Technology and information

sources. The proposal must delineate

the sources of information which will be

used to create the informational

foundation of the resource center.

Sources may include those internal to

the Center (including staff expertise),

but it is expected that many sources will

be external. Factors that may be

considered include: Strength of core

competency in the proposed area of

activity; demonstrated access to relevant

technical or information sources

external to the organization.

(4) Degree of integration with the

manufacturing extension partnership

and other technical assistance

providers. The proposal must

demonstrate that the source center will

be integrated into the system of services

provided by the NIST Manufacturing

Extension Partnership and other

technical assistance providers. Factors

that may be considered include: Ability

of the target population including MEP

Extension Centers to access the resource

center; and methodology for

disseminating or promoting use of the

resource center especially within the

MEP system.

(5) Coordination with other relevant

organizations. Wherever possible the

project should be coordinated with and

leverage other organizations which are

developing or have expertise on similar

tools or techniques. If no such

organizations exist, the proposal should

show that this is the case. Applicants

will need to describe how they will

coordinate to allow for increased

economies of scale and to avoid

duplication. Factors that may be

considered include: Demonstrated

understanding of existing organizations

and resources relevant to the proposed

project; and adequate linkages and

partnerships with existing organizations

and clear definition of those

organizations’ roles in the proposed

activities.

(6) Program evaluation. The applicant

should specify plans for evaluation of

the effectiveness of the proposed

resource center and for ensuring

continuous improvement. Factors that

may be considered include:

Thoroughness of evaluation plans,

including internal evaluation for

management control, external

evaluation for assessing outcomes of the

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Rules and Regulations 4087

activity, and ‘‘customer satisfaction’’

measures of performance; and the

proposer’s plan must include

documentation, analysis of the results,

and must show how the results can be

used in improving the resource center.

(7) Management experience and

Plans. Applicants should specify Plans

for proper organization, staffing, and

management of the implementation

process. Factors that may be considered

include: Appropriateness and authority

of the governing or managing

organization to conduct the proposed

activities; qualifications and experience

of the project team and its leadership to

conduct the proposed activity;

soundness of any staffing plans,

including recruitment, selection,

training, and continuing professional

development; and appropriateness of

the organizational approach for carrying

out the proposed activity.

(8) Financial plan. Applicants should

show the relevance and cost

effectiveness of the financial plan for

meeting the objectives of the project; the

firmness and level of the applicant’s

total financial support for the project;

and a plan to maintain the program after

the cooperative agreement has expired.

Factors that may be considered include:

Reasonableness of the budget, both in

income and expenses; strength of

commitment and amount of the

proposer’s cost share; effectiveness of

management plans for control of the

budget; and appropriateness of

matching contributions.

§ 291.5 Proposal selection process.

The proposal evaluation and selection

process will consist of three principal

phases: Proposal qualification; proposal

review and selection of finalists; and

award determination.

(a) Proposal qualification. All

proposals will be reviewed by NIST to

assure compliance with the proposal

content and other basic provisions of

this notice. Proposals which satisfy

these requirements will be designated

qualified proposals; all others will be

disqualified at this phase of the

evaluation and selection process.

(b) Proposal review and selection of

finalists. NIST will appoint an

evaluation panel composed of NIST and

in some cases other federal employees

to review and evaluate all qualified

proposals in accordance with the

evaluation criteria and values set forth

in this notice. A site visit may be

required to make full evaluation of a

proposal. From the qualified proposals,

a group of finalists will be numerically

ranked and recommended for award

based on this review.

(c) Award determination. The Director

of the NIST, or her/his designee, shall

select awardees based on total

evaluation scores, geographic

distribution, and the availability of

funds. All three factors will be

considered in making an award. Upon

the final award decision, a notification

will be made to each of the proposing

organizations.

§ 291.6 Additional requirements; federal

policies and procedures.

Recipients and subrecipients are

subject to all Federal laws and Federal

and Department of Commerce policies,

regulations, and procedures applicable

to Federal financial assistance awards.

[FR Doc. 95–1313 Filed 1–19–95; 8:45 am]

BILLING CODE 3510–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 90N–0376]

RIN 0905–AA73

Current Good Manufacturing Practice

in Manufacturing, Processing, Packing,

or Holding of Drugs; Amendment of

Certain Requirements for Finished

Pharmaceuticals

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revising certain

requirements of the current good

manufacturing practice (CGMP)

regulations for finished human and

veterinary pharmaceuticals. The

changes include clarifying the degree of

discretion provided to manufacturers to

determine whether separate or defined

areas of production and storage are

necessary, clarifying the standard used

to determine the degree of scrutiny

necessary to check the accuracy of the

input to and output from computer

systems, exempting investigational new

drug products from bearing an

expiration date, permitting the use of a

representative sampling plan for the

examination of reserve samples, and

clarifying the manufacturer’s

responsibilities regarding batch records

during the annual evaluation of drug

product quality standards. These

revisions will reduce regulatory

burdens.

EFFECTIVE DATE: February 21, 1995.

FOR FURTHER INFORMATION CONTACT:

Howard P. Muller, Jr., Center for Drug

Evaluation and Research (HFD–

362), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1046,

Paul J. Motise, Center for Drug

Evaluation and Research (HFD–

323), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1089, or

William G. Marnane, Center for

Veterinary Medicine (HFV–143),

Food and Drug Administration,

7500 Standish Pl., Rockville MD

20855, 301–594–0678.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 14,

1981 (46 FR 36332), FDA announced

that it was undertaking a review of

existing regulations with the goal of

minimizing regulatory burdens while

maintaining an acceptable level of

consumer protection. The public was

invited to submit information to assist

the agency in deciding the priority of

review. FDA invited data that would

enable the agency to identify specific

existing regulations or groups of

regulations perceived to be

unnecessarily costly, burdensome, or

without public benefit, and on the

potential savings to be derived from

revising or removing regulations.

In the Federal Register of July 2, 1982

(47 FR 29004), FDA announced its

review priorities based on comments

from 125 individuals and organizations.

One area selected for regulatory review

was part 211 (21 CFR part 211), the

regulations that govern CGMP for

finished pharmaceuticals.

This, in turn, led to an internal

retrospective review that resulted in

recommendations to the agency. As a

result of the agency review, in the

Federal Register of February 12, 1991

(56 FR 5671), FDA issued a proposed

rule incorporating the recommendations

resulting from the review (hereinafter

referred to as the proposed rule).

Consideration of these comments and

any resulting revisions have been

incorporated into this final rule and are

discussed in detail below.

The agency’s review of CGMP

regulations is ongoing and FDA

anticipates further revisions based on

the agency’s experience with the

regulations, enforcement efforts, and

communications with industry and the

general public.