The good laboratory practice (GLP)
regulations are intended to assure the quality and integrity of the
safety data submitted to FDA in support of the approval of
regulated products. The required information will help assure that
only safe products are approved for marketing. Respondents to the
collection are those submitting applications to FDA for research or
marketing permits.
Burden reduction reflects
correction of mathematical error recorded previously. This is
explained in the Supporting Statement at Q.15.
$0
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
No
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.