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. In
accordance with 5 CFR 1320, OMB is withholding approval of this
information collection. Prior to the publication of the final rule,
the agency must provide to OMB a summary of all comments pertaining
to the information collection burden imposed by this rule and any
changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
0
0
Any person to whom a procurement quota
has been issued, authorizing that person to procure and use a
quantity of a basic class of controlled substances listed in
Schedules I or II and ephedrine, pseudoephedrine,
phenylpropanolamine during the current calendar year, shall, at or
before the time of giving an order to another registrant requiring
the distribution of a quantity of such basic class and the
chemical, certify in writing to such other registrant that the
quantity of such basic class and list I chemical ordered does not
exceed the person's unused and available procurement quota of such
basic class and chemical for the current calendar year. Registrants
shall not fill an order from a person required to apply for a
procurement quota unless the order is accompanied by such a
certification. Manufacturers procuring schedules I and II
controlled substances or list I chemicals must maintain a copy of
the certification they provide with their order for a period of two
years from the date of the certification. 21 U.S.C. 826; 21 CFR
1303.12(f), 1315.32(h).
This is a new collection being
created as part of the DEA’s "Management of Quotas for Controlled
Substances and List I Chemicals" rulemaking, RIN 1117-AB49. The DEA
is proposing to revise the regulations for procurement quota
certification by requiring all DEA registrants supplying schedules
I and II controlled substances or list I chemicals to DEA
manufacturers to obtain certification of the manufacturer’s
procurement quota before completing the transaction.
$0
No
No
No
No
No
No
Uncollected
Alana Moore 202 598-2403
alana.j.moore@usdoj.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.