Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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2.11 Smoke-Free Workplace


The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

2.12 Prohibited Research


NIH Appropriation Acts have limited the use of NIH funding for a number of years and typically continue the same limitations from year to year. These legislative mandates appear in the Public Law 112-74 that authorizes NIH appropriations:

BAN ON FUNDING OF HUMAN EMBRYO RESEARCH (Section 508)


NIH is prohibited from using appropriated funds to support human embryo research. Grant, cooperative agreement, and contract funds may not be used for: "(a)…(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR part 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). (b) For purposes of this section, the term `human embryo or embryos' includes any organism not protected as a human subject under 45 CFR part 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells."

The NIH has published final guidelines on the allowability of Federal funds to be used for research on human embryonic stem cell lines at http://stemcells.nih.gov/index.asp.


LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES (Section 509)


"(a) None of the funds made available in this Act may be used for any activity that promotes the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established by section 202 of the Controlled Substances Act (21 U.S.C.812). (b)The limitation in subsection (a) shall not apply when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage."

RESTRICTION ON DISTRIBUTION OF STERILE NEEDLES (Section 523)


"Notwithstanding any other provision of this Act, no funds appropriated in this Act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug."

RESTRICTION ON ABORTIONS (Section 506)


"(a) None of the funds appropriated under this Act, and none of the funds in any trust fund to which funds are appropriated under this Act, shall be expended for any abortion."

(b) None of the funds appropriated in this Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for health benefits coverage that includes coverage of abortion.

(c) The term “health benefits coverage” means the package of services covered by a managed care provider or organization pursuant to a contract or other arrangement.”

EXCEPTION TO RESTRICTION ON ABORTIONS (Section 507)


“(a) The limitations established in the preceding section shall not apply to an abortion—

(1) if the pregnancy is the result of an act of rape or incest; or

(2) in the case where a woman suffers from a physical disorder, physical injury, or physical illness, including a life endangering physical condition caused by or arising from the pregnancy itself, that would, as certified by a physician, place the woman in danger of death unless an abortion is performed.

(b) Nothing in the preceding section shall be construed as prohibiting the expenditure by a State, locality, entity, or private person of State, local, or private funds (other than a State’s or locality’s contribution of Medicaid matching funds).

(c) Nothing in the preceding section shall be construed as restricting the ability of any managed care provider from offering abortion coverage or the ability of a State or locality to contract separately with such a provider for such coverage with State funds (other than a State’s or locality’s contribution of Medicaid matching funds).

(d) (1) None of the funds made available in this Act may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions.

(2) In this subsection, the term ‘‘health care entity’’ includes an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.

2.13 Select Agent Research


The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland or other criminal acts. The Act was implemented, in part, through regulations published by CDC at 42 CFR 73 http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf, Select Agents and Toxins.

As a term of award, grantees who conduct research involving select agents (see 42 CFR 73 for the list; and 7 CRF 331 and 9 CFR 121 for the relevant animal and plant pathogens) are reminded that they must complete registration with CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research involving select agents if the final registration certificate is denied.

In addition to the above requirements, research involving both select agents and recombinant DNA is also subject to the NIH Guidelines for Research Involving DNA Molecules (NIH Guidelines) (see Section 2.9 Research Involving Recombinant DNA, including Human Gene Transfer Research in this subsection for applicability of these guidelines).

For additional information regarding select agent research, see the following Web sites maintained by NIH, CDC, and USDA:

NIH Office of Extramural Research Select Agent Information: http://grants.nih.gov/grants/policy/select_agent/

Center for Disease Control Select Agent Program:


http://www.cdc.gov/od/sap/index.htm

Center for Disease Control Select Agent Program Guidelines: http://www.cdc.gov/od/sap/guidelines.htm

Center for Disease Control Select Agent Program Public Laws and Regulations: http://www.cdc.gov/od/sap/regulations.htm

Center for Disease Control Select Agent Program Related Links: http://www.cdc.gov/od/sap/regulations.htm

Animal and Plant Health Inspection Service (APHIS) Select Agent Program: http://www.aphis.usda.gov/programs/ag_selectagent/

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