[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