OMB files this
comment in accordance with 5 CFR 1320.11( c ). This OMB action is
not an approval to conduct or sponsor an information collection
under the Paperwork Reduction Act of 1995. This action has no
effect on any current approvals. If OMB has assigned this ICR a new
OMB Control Number, the OMB Control Number will not appear in the
active inventory. For future submissions of this information
collection, reference the OMB Control Number provided. The agency
will resubmit this collection when the final rule is issued.
Inventory as of this Action
Requested
Previously Approved
12/31/2017
36 Months From Approved
01/31/2018
36,150
0
36,150
1,304,157
0
1,304,157
0
0
0
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.
The information collection is
being revised by rulemaking. Proposed changes are discussed in the
agency's supporting statement.
$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.