[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Proposed Rules]
[Pages 49529-49531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23775]
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DEPARTMENT OF JUSTICE
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 (202)
307-7183.
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
