Manufacturer Reporting

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