HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/60.fr.49529

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<ARTICLE>
Date="09/26/95"
Citation="60 FR 49529"
Group="legal"
Type="PROPOSED RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Manufacturer Reporting"
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21 CFR Part 1310

[DEA-135P/RIN 1117-AA30]

Manufacturer Reporting

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
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21 CFR Part 1310

[DEA-135P/RIN 1117-AA30]

Manufacturer Reporting

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
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SUMMARY: This proposed rule is issued by the Deputy Administrator
of the Drug Enforcement Administration (DEA) to implement provisions
of the Domestic Chemical Diversion Control Act of 1993 (Public
Law 103-200) (DCDCA) to specify certain reporting requirements
for manufacturers of listed chemicals. In a proposed rule published
in the Federal Register on October 13, 1994 (59 FR 51887), the
DEA previously proposed regulations to implement the requirement
that bulk manufacturers of listed chemicals report certain data
to the DEA. After receiving comments from the affected chemical
industry, on December 9, 1994 (59 FR 63738) the DEA withdrew
the portions of the proposed rule pertaining to manufacturer
reporting requirements, for further study and consultation with
industry. The proposed manufacturer reporting requirements as
specified in this Notice of Proposed Rulemaking have been prepared
with additional input from the affected chemical industry.

DATES: Written comments and objections must be received by November
27, 1995.

ADDRESSES: Comments and objections should be submitted in quintuplicate
to the Administrator, Drug Enforcement Administration, Washington
DC 20537, Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Howard McClain Jr., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control,
Drug Enforcement Administration, Washington, D.C. 20537, Telephone
[phone].

SUPPLEMENTARY INFORMATION: The Domestic Chemical Diversion Control
Act of 1993 (Pub. L. 103-200) (DCDCA) was signed into law on
December 17, 1993 and became effective on April 16, 1994. A
final rule implementing most of the provisions of the DCDCA
(60 FR 32447) was published on June 22, 1995.

   The DCDCA amended 21 U.S.C. 830(b) to require that regulated
persons who manufacture a listed chemical (other than a drug
product that is exempted under 21 U.S.C. 802(39)(A)(iv) report
annually to DEA information detailing the specific quantities
manufactured. The purpose of this provision is to provide DEA
with information on the amounts of listed chemicals available
in the U.S. and to enable the DEA to provide the International
Narcotics Control Board (INCB) with aggregate data regarding
the production and availability of chemicals controlled under
provisions of the 1988 United Nations Convention Against Illicit
Traffic in Narcotic Drugs and Psychotropic Substances.
   In a proposed rule published in the Federal Register on October
13, 1994 (59 FR 51887), the DEA proposed regulations to implement
the provisions of the DCDCA. That notice proposed to amend Section
1310.03 to require that bulk manufacturers of listed chemicals
report certain data to the DEA. In addition, Sections 1310.05
and 1310.06 were proposed to be amended to set forth the specific
requirements for the chemical manufacturer reports. Comments
received from the affected industry expressed concerns that
the proposed manufacturer reports as set forth in Sections 1310.05
and 1310.06 may duplicate existing reports made by chemical
manufacturers, did not take into consideration the treatment
of confidential business information and were unduly burdensome.
Therefore, on December 9, 1994, the DEA published a notice in
the Federal Register (59 FR 63738) to withdraw the proposed
provisions for manufacturer reporting (as set forth in 1310.05
and 1310.06) for reassessment and consultation with industry.
Subsequent to the withdrawal, the DEA has solicited further
input and advice from representatives of the affected chemical
industry. Following

---- page 49530 ----

further discussions and consultation with the Chemical Manufacturers
Association (CMA) and other relevant industry groups, the DEA
has prepared the proposed regulations for manufacturer reporting.
   These reporting requirements will apply only to bulk manufacturers
of listed chemicals. The term bulk manufacturer as used in this
regulation means a person who manufactures a listed chemical
by means of chemical synthesis or by extraction from other substances.
It does not include persons whose sole activity consists of
repackaging or relabeling listed chemical products or the manufacture
of drug dosage form products which contain a listed chemical.
   Industry groups expressed concerns regarding the burden of
generating special reports to satisfy this new reporting requirement.
In order to minimize such a burden and avoid duplicate reporting,
the DEA will accept existing reports which contain the required
data, provided the data is separate or readily retrievable from
other data in the report. Thus, if an existing standard industry
report contains the information required in Section 1310.06(h),
the preparation of a separate report will not be necessary.
   Industry groups also expressed concerns that the DEA would
require each manufacturer to perform ``mass balance'' accountabilities
for each listed chemical. In addition, industry representatives
also raised concerns regarding such accountabilities as they
pertain to the production of chemical mixtures. However, the
DEA wishes to emphasize that the purpose of this reporting requirement
is to allow the DEA to monitor the overall availability of each
listed chemical in the U.S. and report aggregate information
to the INCB, when requested. For each listed chemical, each
manufacturer is required to report annually to DEA (1) the year-
end inventory, (2) the aggregate quantity manufactured, (3)
the aggregate quantity used for internal consumption and (4)
the aggregate quantity converted to a product exempted under
Section 1310.01(f)(1)(iv) or 1310.01(f)(1)(v) during the preceding
calendar year. While manufacturers are required to report the
quantities of listed chemicals used in the production of exempted
products (e.g. exempted drug products and chemical mixtures),
the manufacturer is not required to report data regarding the
aggregate quantity of the exempted products produced.
   For purposes of these reporting requirements, internal consumption
shall be defined as any quantity of a listed chemical otherwise
not available for further resale or distribution to any outside
party. Internal consumption shall include (but not be limited
to) quantities used for quality control testing, quantities
consumed in-house or production losses. Internal consumption
does not include the quantities of a listed chemical consumed
in the production of exempted products. (These quantities used
in the production of exempted products shall be reported separately.)
   Industry groups also expressed concern regarding the protection
of data provided to the DEA if it is designated as confidential
business information. The DEA has considerable experience in
safeguarding similar confidential business information. The
issue of protection of confidential business information has
been addressed by the DEA in the Federal Register Notice published
on June 22, 1995 which finalizes specific provisions of the
DCDCA (60 FR 32453).
   The release of confidential business information that is
protected from disclosure under Exemption 4 of the Freedom of
Information Act, 5 U.S.C. 552(b)(4) (FOIA), is governed by section
830(c) of the CSA (21 U.S.C. 830(c)) and the Department of Justice
procedures set forth in 28 CFR 16.7.
   Section 830(c) of the CSA provides that information collected
under section 830 that is protected from disclosure under Exemption
4 may only be released in circumstances related to the enforcement
of controlled substance or chemical laws, customs laws, or for
compliance with U.S. obligations under treaty or international
agreements. The Department of Justice procedures establish that
if a FOIA request is received for release of information that
is protected under Exemption 4, the submitter of the protected
information must be notified of such a request, given an opportunity
to object to the disclosure and allowed to provide justification
as to why the information should not be disclosed.
   In addition to the statutory and regulatory requirements,
DEA has established internal guidelines governing the handling
of confidential business information, including provisions that
the material be maintained in locked containers, that access
to the information be on a need-to-know basis, and that any
disclosure under section 830 be made only pursuant to a non-
disclosure agreement by the receiving party.
   As proposed, data provided under these reporting requirements
shall be submitted annually to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration, Washington DC 20537,
on or before the 15th day of March of the year immediately following
the calendar year for which submitted.Therefore, the first annual
reports which detail manufacturing data for calendar year 1995,
shall be submitted on or before March 15, 1996.
   The Attorney General has delegated authority under the CSA
and all subsequent amendments to the CSA to the Administrator
of the DEA (28 CFR 0.100). The Administrator, in turn, has redelegated
this authority to the Deputy Administrator pursuant to 28 CFR
0.104. The Deputy Administrator hereby certifies that this proposed
rulemaking will have no significant impact upon entities whose
interests must be considered under the Regulatory Flexibility
Act, 5 U.S.C. 601 et seq. The DEA estimates that only approximately
210 manufacturers of listed chemicals will be impacted by these
reporting requirements. The impact is minimal since the requested
information is frequently maintained in the normal course of
business operation. In an effort to further minimize the impact
of these reporting requirements and avoid duplicate reporting,
the DEA will accept existing reports which contain the required
the required data, the DEA will accept existing reports which
contain the required data, provided the data is separate or
readily retrievable from other data in the report.
   The proposed rule is not a significant regulatory action
and therefore has not been reviewed by the Office of Management
and Budget pursuant to Executive Order 12866.
   This action has been analyzed in accordance with the principles
and criteria in E.O. 12612, and it has been determined that
the proposed rule does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1310

   Drug traffic control, Reporting and recordkeeping requirements,
List I and List II chemicals.
   For reasons as set out above, 21 CFR part 1310 is proposed
to be amended as follows:

PART 1310-[AMENDED]

   1. The authority citation for part 1310 continues to read
as follows:

   Authority: 21 U.S.C. 802, 830, 871(b).
   2. Section 1310.03 is proposed to be amended by redesignating
the introductory text as paragraph (a) and adding a new paragraph
(b) to read as follows:

---- page 49531 ----


sec 1310.03   Persons required to keep records and file reports.

   (a) * * *
   (b) Each regulated person who manufacturers a listed chemical
shall file reports regarding such manufactures as specified
in sec 1310.05.
   3. Section 1310.05 is proposed to be amended by adding a
new paragraph (d) to read as follows:

sec 1310.05   Reports.
*     *     *     *     *
   (d) Each regulated bulk manufacturer of a listed chemical
shall submit manufacturing, inventory and use data on an annual
basis as set forth in sec 1310.06(h). This data shall be submitted
annually to the Drug and Chemical Evaluation Section, Drug Enforcement
Administration (DEA), Washington, DC 20537, on or before the
15th day of March of the year immediately following the calendar
year for which submitted. This reporting requirement does not
apply to drug or other products which are exempted under sec 1310.01(f)(1)(iv)
or sec 1310.01(f)(1)(v) except as set forth in sec 1310.06(h)(5).
If an existing standard industry report contains the information
required in sec 1310.06(h) and such information is separate or
readily retrievable from the report, that report may be submitted
in satisfaction of this requirement. Each report shall be submitted
to the DEA under company letterhead and signed by an appropriate,
responsible official. For purposes of this paragraph only, the
term regulated bulk manufacturer of a listed chemical means
a person who manufactures a listed chemical by means of chemical
synthesis or by extraction from other substances. The term bulk
manufacturer does not include persons whose sole activity consists
of the repackaging or relabeling of listed chemical products
or the manufacture of drug dosage form products which contain
a listed chemical.
   4. Section 1310.06 is proposed to be amended by adding a
new paragraph (h) to read as follows:

sec 1310.06   Content of records and reports.
*     *     *     *     *
   (h) Each annual report required by sec 1310.05(d) shall provide
the following information for each listed chemical manufactured:
   (1) The name, address and chemical registration number (if
any) of the manufacturer and person to contact for information.
   (2) The aggregate quantity of each listed chemical that the
company manufactured during the preceding calendar year.
   (3) The year-end inventory of each listed chemical as of
the close of business on the 31st day of December of each year.
(For each listed chemical, if the prior period's ending inventory
has not previously been reported to DEA, this report should
also detail the beginning inventory for the period.)
   (4) The aggregate quantity of each listed chemical used for
internal consumption during the preceding calendar year.
   (5) The aggregate quantity of each listed chemical manufactured
and converted to a product exempted under sec 1310.01(f)(1)(iv)
or sec 1310.01(f)(1)(v) during the preceding calendar year.
   (6) Data shall identify the specific isomer, salt or ester
when applicable but quantitative data shall be reported as anhydrous
base or acid to the nearest kilogram.

   Dated: September 11, 1995.

Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.

[FR Doc. 95-23775 Filed 9-25-95; 8:45 am]
BILLING CODE 4410-09-M


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The Contents entry for this article reads as follows:

Domestic Chemical Diversion Control Act of 1993; implementation:
  List I chemicals; manufacturers, distributors, importers, and exporters-
    Manufacturer reporting requirements, 49529
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