[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Proposed Rules]
[Pages 49811-49812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23997]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. 95N-0295]
Prominence of Name of Distributor of Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the labeling regulations to remove the requirement that the
manufacturer's name be more prominent than the distributor and to
permit the names of distributors to be prominently displayed on
biological product container labels, package labels, and labeling. This
proposed change in the labeling requirements is intended to facilitate
flexible manufacturing, packaging, distribution, and labeling
arrangements, and to harmonize labeling regulations applicable to
biologic products licensed under the Public Health Service Act with the
corresponding labeling regulations applicable to drugs approved under
the Federal Food Drug and Cosmetic Act (the act). FDA is considering
further revisions to the labeling requirements.
DATES: Comments by December 26, 1995.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Jean M. Olson or Tracey Forfa, Center
for Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-594-3074.
SUPPLEMENTARY INFORMATION:
I. Background
This proposed rule is being issued in accordance with the
principles set forth in Executive Order 12866 and the steps described
in President Clinton's memorandum of March 4, 1995, announcing his
``Regulatory Reinvention Initiative.'' Executive Order 12866 directs
Federal agencies and the Office of Information and Regulatory Affairs
to implement measures that will reform and streamline the regulatory
process. President Clinton's memorandum of March 4, 1995, sets forth
four steps toward regulatory reform, one of which instructs agencies to
revise those regulations that are in need of reform. FDA believes that
this regulation is in keeping with these principles without
compromising the agency's commitment to protect the public health.
Under Executive Order 12866, FDA published a notice in the Federal
Register of January 20, 1994 (59 FR 3043), announcing FDA's plan to
review and evaluate all significant regulations for their effectiveness
in protecting the public health, while avoiding an unnecessary
regulatory burden. In the Federal Register of June 3, 1994 (59 FR 28821
and 28822), FDA published two notices announcing the review and
evaluation of certain biologic and blood and blood product regulations
by the Center for Biologics Evaluation and Research (CBER). The intent
of the review and evaluation was to identify those regulations that are
outdated, burdensome, inefficient, duplicative, or otherwise unsuitable
or unnecessary.
FDA held a public meeting on January 26, 1995, that was announced
in the Federal Register on January 9, 1995 (60 FR 2351). The public
meeting was a forum for the public to voice comments regarding the
review and evaluation of regulations being undertaken by CBER.
Some of the comments from the public meeting held to discuss the
CBER regulations review questioned the need for the manufacturer's name
to be the most prominent name on the label. Requests were made asking
that CBER consider revising the labeling regulations so that developers
of innovative new products would be able to have their names on the
label, even if they contract out the manufacturing of the product. The
labeling regulation addressing the name of the selling agent or
distributor (Sec. 610.64 (21 CFR 610.64)), currently requires that the
name of the manufacturer of the biological product be more prominently
displayed on the label than the name of the selling agent or
distributor. FDA announced its intention to issue a proposed rule to
revise Sec. 610.64 in the April 1995 National Performance Review
Report, ``Reinventing Regulation of Drugs and Medical Devices.'' FDA
made a commitment to issue the proposed rule within 6 months of the
report.
II. The Proposed Rule
The proposed rule is intended to facilitate flexible manufacturing,
packaging, distribution, and labeling arrangements. FDA recognizes that
small innovator firms may not have the facilities to manufacture
commercial quantities of the product. Such innovator firms want the
flexibility to contract out part or all of the manufacturing steps
without being required to feature the product manufacturer's name more
prominently on the label. In some cases manufacturers and distributors
would prefer to have the option and the freedom to negotiate with each
other for the prominence of the various firm names on the label.
The proposed rule is also intended to reduce the regulatory burden
on manufacturers who produce both biologics and other drugs by
harmonizing this labeling requirement with the labeling provisions
approved
[[Page 49812]]
under the act (21 CFR 201.1), applicable to drugs.
The proposed rule removes the requirement that the manufacturer's
name be more prominent than the distributor's name. The proposed rule
permits a number of options for identifying the distributor so that the
identification on the label may be consistent with the actual
circumstances of the sale and distribution of the product. In cases
where a distributor is named on the label, the proposed rule would
require the use of a qualifying phrase to distinguish the manufacturer
and distributor of the product. The requirement that the name, address,
and license number of the manufacturer also appear on the container
label (21 CFR 610.60) and package label (21 CFR 610.61) would remain
unchanged.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(d)(10) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
FDA has assessed the economic impact of the proposed rule under the
Regulatory Flexibility Act. Under the Regulatory Flexibility Act, FDA
must analyze regulatory options that would minimize any significant
impact of the rule on small entities. This amendment does not require
any entity to change its current procedures. At this time FDA cannot
quantify the benefits of the rule. However, it may benefit
manufacturers or distributors by allowing greater flexibility in
labeling. The amendment provides labeling alternatives by allowing the
names of distributors to be as (or more, or less) prominent than names
of manufacturer(s) on the label. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
V. Paperwork Reduction Act of 1980
This rule removes an unnecessary labeling requirement. The
immediate effect of the rule allowing names of distributors to be as
prominent as names of manufacturers is neutral. The rule does not
require any changes in current labels. Accordingly, Office of
Management and Budget clearance is not required under the Paperwork
Reduction Act of 1980 (44 U.S.C. 3501, et seq.).
VI. Request for Comments
Interested persons may, on or before December 26, 1995, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Lists of Subjects in 21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be
amended as follows:
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
1. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, and 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
2. Section 610.64 is revised to read as follows:
Sec. 610.64 Name and address of distributor.
The name and address of the distributor of a product may appear on
the label provided that the name, address, and license number of the
manufacturer also appears on the label and the name of the distributor
is qualified by one of the following phrases: ``Manufactured for ------
----'', ``Distributed by ----------'', ``Manufactured by ---------- for
------------'', ``Manufactured for ---------- by ----------'',
``Distributor: ----------'', or ``Marketed by ----------'' . The
qualifying phrases may be abbreviated.
Dated: September 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23997 Filed 9-26-95; 8:45 am]
BILLING CODE 4160-01-F