SOLICITATION NOTICE
A -- Modification to Contract No. HHSN275201200007C entitled Folic Acid and Zinc Supplementation Trial - Trial Clinical Centers
- Notice Date
- 12/5/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- HHSN275201200007C
- Archive Date
- 1/4/2014
- Point of Contact
- Megan Gnall, Phone: 301-435-6924, Elizabeth D Osinski, Phone: 301-435-6947
- E-Mail Address
-
megan.gnall@nih.gov, eo43m@nih.gov
(megan.gnall@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate a modification to Contract No. HHSN275201200007C entitled Folic Acid Supplementation and Semen Quality Trial - Trial Clinical Centers, on a sole source basis to the University of Utah, under the authority 41 U.S.C. 253 (c)(1), FAR 6.302-1(a)(2). Specifically, female partners of participants in the Folic Acid and Zinc Supplementation Trial (FAZST) will be invited to participate in the Impact of Diet, Exercise And Lifestyle on Fecundity (IDEAL) study. The FAZST trial is an ongoing study in the Epidemiology Branch to evaluate the effects of folic acid and zinc supplementation in males on semen quality parameters and pregnancy outcomes among 2400 couples seeking fertility treatment. Currently, female partners are only minimally involved in FAZST, with a single baseline visit and short monthly web-based questionnaires to track pregnancy outcomes, along with medical chart abstraction to assess fertility treatments and verify reported pregnancy outcomes. Female partners of FAZST couples create a potential cohort of women from whom to study the effects of dietary and lifestyle factors on pregnancy outcomes among couples seeking fertility treatment. The current initiative would be a modification to Contract No. HHSN275201200007C to add additional detailed follow-up (both questionnaires and biospecimen collection) to the female partners of the FAZST trial. The goal of the proposed study is to evaluate the impacts of modifiable lifestyle factors on fertility in the context of a couple-based approach across a spectrum of fertility and treatment. Female partners of FAZST participants provide a unique and valuable resource, bringing about an opportunity to follow a large, prospective cohort of women undergoing fertility treatment, while leveraging precious resources to create a rich data source for future studies. This modification will provide for a study to investigate the impact of dietary and other modifiable lifestyle factors in both male and female partners on prospectively measured pregnancy outcomes among couples seeking fertility treatment. The NICHD anticipates that the services above can only be done as a part of the existing infrastructure of the FAZST trial. Awarding a new contract to another contractor would require them to duplicate the infrastructure for participant recruitment, database development, study publicity, staff training, and recruitment of male partners. As the FAZST trial is already in place, extensive resources have been used to prepare the research site for recruitment, including dedicated office space for study activities and training for all staff on current data systems and study procedures. In addition, a large web-based database for data collection, including online questionnaires and biospecimens tracking, storage, and shipping procedures have already been developed and are currently in place. All of this work would need to be duplicated in order to complete the new requirements. Importantly, adding follow-up for the female partners creates a rich and unique data source for studying lifestyle factors of both the male and female partners. If the proposed work were to be done by another contractor, it would involve duplicated effort to recruit and obtain information on their male partners to create the same database of information for future study. The couple-based approach for studying dietary and other modifiable lifestyle factors on reproduction is critical for moving the field forward and informing preconception guidance. This would result in unacceptable delays, substantial duplication of effort, and increased costs to the government. This is not a request for proposals. However, if any responsible source believes it can perform the above requirement, they may submit three (3) copies of their capability statement for consideration by the NICHD to Megan Gnall, Contracting Officer, NICHD, CMB, NIH, 6100 Executive Blvd., MSC 7510, Bethesda, Maryland, 20892-7510 (or overnight courier: 6100 Executive Blvd., Rockville, Maryland, 20852). Phone number 301-435-6924 and fax number 301-402-3676. All responses must be received in writing no later than December 20, 2013 and must contain material in sufficient detail to allow the NICHD to determine if the party can perform this requirement. The capability statement will be considered solely for the purposes of determining whether to conduct a competitive procurement. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/HHSN275201200007C/listing.html)
- Place of Performance
- Address: University of Utah, Office of Sponsored Projects, 201 South President's Circle, Rm 406, Salt Lake City, Utah, 84112, United States
- Zip Code: 84112
- Zip Code: 84112
- Record
- SN03246120-W 20131207/131205234628-642f7c5798e2ade8285417e57c2fd5f8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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