Grants and cooperative agreements; availability, etc.: care worker glove protection during surgery and effects of storage, chemicals, and disinfectants on glove integrity; evaluation,

[Federal Register: May 21, 1998 (Volume 63, Number 98)]

[Notices]

[Page 27981-27983]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21my98-113]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 98090]

Evaluation of Health-Care Worker Glove Protection During Surgery and Effects of Storage, Chemicals, Disinfectants on Glove Integrity; Availability of Funds

1. Purpose

   The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 1998 funds for a cooperative agreement program for the evaluation of health-care worker glove protection during surgery and the effects of storage, chemicals, and disinfectants on glove integrity. This program addresses the ``Healthy People 2000'' priority area(s) area of Occupational Safety and Health.

   The purpose of the program is to evaluate gloves (non-latex polymer e.g., nitrile, vs natural latex rubber (NLR)) in surgery; (veterinary surgery is suggested as a surrogate for human surgery) and to evaluate the effects of storage conditions, disinfectants, detergents, other chemicals, and blood and body fat on vinyl, NLR, and non-latex polymer examination gloves and latex and non-latex polymer surgical gloves.

2. Eligible Applicants

   Applications may be submitted by public and private nonprofit and for-profit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents.

   Note: Pub. L. 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

3. Availability of Funds

   Approximately $600,000 is available in FY 1998 to fund approximately three awards, preferably at least one in each category (A and B). It is expected that

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   the average award will be $200,000, ranging from $150,000 to $300,000. It is expected that the awards will begin on or about September 1, 1998, and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may change.

   Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

   Use of Funds: The applicant should allocate funds for at least one annual CDC/NIOSH directed meeting.

   Programmatic Interest

   The applicant may address either or both of the components identified below:

1. Evaluate the degradation characteristics of examination and surgical gloves.

2. Evaluation of the similarities and differences of NLR and non- latex gloves during surgery including protection of wearer from needlestick and other sharp injuries (puncture and tear resistance) and worker acceptance.

4. Cooperative Agreement Requirements

   In conducting activities to achieve the purpose of this program, the recipient will be responsible for activities under A. (Recipient Activities), and CDC/NIOSH will be responsible for the activities listed under B. (CDC/NIOSH Activities). A. Recipient Activities

   1. Develop, implement, and evaluate a study protocol.

   2. Provide statistical analysis of the data.

   3. Disseminate study results to the scientific community.

   4. Collaborate with CDC/NIOSH on these activities and the activities listed below. B. CDC/NIOSH Activities

   1. Providing scientific and technical collaboration including study design and protocol development, and data analysis.

   2. Monitor and evaluate scientific and operational accomplishments of the project through site visits, telephone calls, and review of technical reports and interim data analysis.

   3. Collaborate with awardee(s) on data analysis, and interpretation of findings.

   4. Review the results of the study and collabroate, where appropriate, in the preparation and publication of results in peer- reviewed journals.

5. Application Content

   Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 25 double-spaced pages, printed on one side, with one inch margins, and unreduced font.

6. Submission and Deadline

   Submit the original and five copies of PHS-398 (OMB Number 0925- 0001)(adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are in the application kit. On or before July 23, 1998, submit the application to: Victoria Sepe, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Announcement 98090, Centers for Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry Road, NE., M/S E-13, Atlanta, Georgia 30305-2209.

   If your application does not arrive in time for submission to the independent review group, it will not be considered in the current competition unless you can provide proof that you mailed it on or before the deadline (i.e., receipt from U.S. Postal Service or a commercial carrier; private metered postmarks are not acceptable).

7. Evaluation Criteria

   Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC. 1. Understanding of the Problem (15%)

   Responsiveness to the objective of the cooperative agreement including: (a) Applicant's understanding of the general objectives of the proposed cooperative agreement, and (b) evidence of ability to design an effective evaluation study. 2. Experience (15%)

   The extent to which the applicant's prior work and experience in developing and performing laboratory assay (Part A) and/or surgical assays (Part B). 3. Goals, Objectives and Methods (35%)

   The extent to which the proposed goals and objectives are clearly stated, time-phased, and measurable. The extent to which the methods are sufficiently detailed to allow assessment of whether the objectives can be achieved for the budget period. Clearly state the evaluation method for evaluating the accomplishments. The extent to which a qualified plan is proposed that will help achieve the goals stated in the proposal. 4. Facilities and Resources (10%)

   The adequacy of the applicant's facilities, equipment, and other resources available for performance of this project. The proposal should include a commitment from the participating institution, as evidenced by a written agreement. For applicants applying to conduct the evaluation of glove performance in surgery, the proposal should include a commitment, as evidenced by a written agreement, from the chief of surgery, head of operating room nursing, and other directors with jurisdiction over the surgical suite, when such exist at the applicant's institution. 5. Project Management and Staffing Plan (15%)

   The extent to which the management staff and their working partners are clearly described, appropriately assigned, and have pertinent skills and experiences. The extent to which the applicant proposes to involve appropriate personnel who have the needed qualifications to implement the proposed plan. The extent to which the applicant has the capacity to design, implement, and evaluate the proposed intervention program. 6. Collaboration (10%)

   The extent to which all partners are clearly described and their qualifications and the extent to which their intentions to participate are explicitly stated. The extent to which the applicant provides proof of support (e.g., letters of support and/or memoranda of understanding) for proposed activities. Evidence or a statement should be provided that these funds do not duplicate already funded components of ongoing projects. 7. Budget Justification (Not Scored)

   The budget will be evaluated to the extent that it is reasonable, clearly justified, and consistent with the intended use of funds. 8. Human Subjects (Not Scored)

   If human subjects will be involved, how will they be protected, i.e., describe the review process which will govern their participation. The applicant must demonstrate that they have met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: (a) The proposed plan for the inclusion of both sexes and racial and

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   ethnic minority populations for appropriate representation; (b) The proposed justification when representation is limited or absent; (c) A statement as to whether the design of the study is adequate to measure differences when warranted; (d) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. 9. Animal Subjects (Not Scored)

   If the proposed project involves research on animal subjects, the applicant must comply with the ``PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions.'' An applicant organization proposing to use vertebrate animals in PHS-supported activities must file an Animal Welfare Assurance with the Office of Protection from Research Risks at the National Institutes of Health.

8. Other Requirements

   Technical Reporting Requirements

   Provide CDC with original plus two copies of:

   1. Semi-annual progress reports including a brief program description and a listing of program goals and objectives accompanied by a comparison of the actual accomplishments related to the goals and objectives established for the period;

   2. financial status report, no more than 90 days after the end of the budget period; and

   3. final financial and performance reports, no more than 90 days after the end of the project period.

   Send all reports to: Victoria Sepe, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry Road, NE., M/S E-13, Atlanta, GA 30305-2209.

   The following additional requirements are applicable to this program. For a complete description of each, see Addendum I (included in the application package).

   AR98-1 Human Subjects Requirements AR98-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research AR98-3 Animal Subjects Requirements AR98-9 Paperwork Reduction Act Requirements AR98-10 Smoke-Free Workplace Requirements AR98-11 Healthy People 2000 AR98-12 Lobbying Restrictions

   1. Authority and Catalog of Federal Domestic Assistance Number

   This program is authorized under Sections 20(a) and 22(e)(7) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a) and 671(e)(7)). The Catalog of Federal Domestic Assistance number is 93.262 for the National Institute for Occupational Safety and Health.

10. Where To Obtain Additional Information

    To receive additional written information call 1-888-GRANTS4. You will be asked to leave your name, address, and phone number and will need to refer to NIOSH Announcement 98090. You will receive a complete program description, information on application procedures, and application forms. CDC will not send application kits by facsimile or express mail. PLEASE REFER TO NIOSH ANNOUNCEMENT NUMBER 98090 WHEN REQUESTING INFORMATION AND SUBMITTING AN APPLICATION.

    If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained by contacting: Victoria Sepe, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Announcement 98090, Centers for Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry Road, NE., M/S E-13, Atlanta, GA 30305-2209, telephone (404) 842-6804, Email address: vxw1@cdc.gov.

    See also the CDC home page on the Internet: http://www.cdc.gov.

    For program technical assistance contact:

    Scott Deitchman, M.D., telephone (404) 639-1534, Email sed2@cdc.gov

    or

    Robert Mullan, M.D., telephone (404) 639-1533, Email rjm1@cdc.gov, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (CDC), HIV Activity, 1600 Clifton Rd., NE., Mailstop D-40, Atlanta, GA 30333.

    National Occupational Research Agenda (NORA): CDC, NIOSH is committed to the program priorities developed by NORA. Copies of the publication, ``The National Occupational Research Agenda'' may be obtained from The National Institute of Occupational Safety and Health, Publications Office, 4676 Columbia Parkway, Cincinnati, OH 45226-1998 or phone 1-800-356-4674, and is available through the NIOSH Home Page, ``http://www.cdc.gov/niosh/nora.html'' .

    Dated: May 14, 1998. Diane D. Porter, Acting Director, National Institute For Occupational Safety and Health, Centers for Disease Control and Prevention (CDC).

    [FR Doc. 98-13516Filed5-20-98; 8:45 am]

    BILLING CODE 4163-19-P