As clarified in
conversations between OMB and NIH on Dec. 26, 2001 and Jan. 11,
2002, this approval covers the Adverse Events Reporting
Requirements. The Research and Research Training grant applications
and related forms were previously approved through 5/2004 and were
not reviewed as part of this submission. Within three years of the
effective date of these adverse event reporting guidelines, (i.e.
prior to 5/2004) NIH shall report to OMB on the utility and burden
of the reporting requirements in the new adverse event reporting
guidelines. Before April 30, 2002 NIH and OMB shall meet to discuss
the best way to ensure meaningful OMB review and public comment on
this package and 0925-0002. NIH will be prepared to resubmit this
package if changes are deemed necessary following these
meetings.
Inventory as of this Action
Requested
Previously Approved
05/31/2004
05/31/2004
05/31/2004
114,407
0
114,407
1,376,468
0
1,377,548
480,000
0
480,000
PHS 398 and 2590 are used to apply for
research project grants, Reserch Career awards (RCA), Institutional
National Research Service Awards and SBIR/STTR Awards. PHS 2271 is
used for NRSA. Some RCA programs and research supplements; PHS 3734
is used when research project is transferring to another
institution and HHS 568 is used to report inventions made during
course of work under grant award. By signing the application the
instution and investigator assure and certify to the Federal
Government full compliance with all applicable Federal laws,
regulations and policies, including reporting of all significant
adverse . . . .
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.