[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Rules and Regulations]
[Pages 57328-57330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28530]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
labeling regulations for biological products to remove the requirement 
that the manufacturer's name be more prominent than that of the 
distributor and to permit the names of distributors to be prominently 
displayed on biological product container labels, package labels, and 
labeling. This change in 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 (the 
PHS Act) with the corresponding labeling regulations for drugs approved 
under the Federal Food, Drug, and Cosmetic Act (the act).

EFFECTIVE DATE: November 18, 1996.

FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, Center for Biologics 
Evaluation and Research (HFM-630), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of September 27, 1995 (60 FR 49811), FDA 
published a proposed rule to amend the labeling regulations to remove 
the requirement that the manufacturer's name be more prominent than the 
distributor's and to permit the names of distributors to be prominently 
displayed on licensed biological product container labels, package 
labels, and labeling. This final rule is being issued in accordance 
with the principles set forth in Executive Order 12866 and the 
Regulatory Reinvention Initiative announced in President Clinton's 
memorandum of March 4, 1995. 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. As part of the Regulatory Reinvention Initiative, a report 
entitled ``Reinventing Drug and Medical Device Regulations'' was issued 
in April 1995 by the President and Vice President. This final rule 
completes a commitment made by FDA in that report to permit greater 
flexibility in the appearance of distributors' names on biological 
product container labeling, package labels, and labeling.
    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 achieving public health goals and in order to reduce or eliminate 
unnecessary regulatory burden. In the Federal Register of June 3, 1994 
(59 FR 28821 and 28822, respectively), 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. Interested persons 
were given until August 17, 1994, to respond to the notices by 
submitting written comments to the Dockets Management Branch. In the 
Federal Register of August 17, 1994 (59 FR 42193), FDA extended the 
comment periods to November 15, 1994, in response to requests to allow 
for additional time for public comment. In the Federal Register of 
November 14, 1994 (59 FR 56448), FDA extended the comment periods to 
February 13, 1995, in response to requests to hold a public meeting 
regarding the biologics regulations under review.
    FDA held a public meeting on January 26, 1995, that was announced 
in the Federal Register of January 9, 1995 (60 FR 2351). The notice of 
public meeting indicated that the public comment period was to close on 
February 13, 1995. The public meeting was a forum for the public to 
voice their comments regarding the review and evaluation of regulations 
being undertaken by CBER.
    Some of the comments from the docket and public meeting questioned 
the need for the manufacturer's name to be the most prominent name on 
the label of a licensed biological product. FDA's regulation addressing 
the name of the selling agent or distributor on biological product 
labeling (Sec. 610.64 (21 CFR 610.64)) required 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. These 
comments requested that CBER consider revising the labeling regulations 
so that developers of innovative new products could place their names 
prominently on the label, even if they contract out the manufacturing 
of the product. In response to the comments, FDA published a proposed 
rule (60 FR 49811) to amend the labeling regulations to permit the 
names of distributors to be prominently displayed on biological product 
container labels, package labels, and labeling.

II. Highlights of the Final Rule

    The final 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 a biological product. Such innovator firms 
that do not hold the license for the product will no longer be required 
to feature the license holder's name more prominently on the label. 
Manufacturers and distributors will have the option to

[[Page 57329]]

negotiate with each other for the prominence of the various firm names 
on the label.
    The final 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 in Sec. 201.1 
(21 CFR 201.1) applicable to drugs approved under the act.
    The final rule removes the requirement that the manufacturer's name 
be more prominent than the distributor's name on product labeling. The 
final rule prescribes a number of options for identifying the 
distributor so that the information on the label is consistent with the 
actual circumstances of the sale and distribution of the product. In 
cases where a distributor is named on the label, the final rule 
requires the use of a qualifying phrase to distinguish the manufacturer 
and distributor of the product. The requirements 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) 
remain unchanged.

III. Comments on the Proposed Rule and FDA Responses

    FDA received five letters of comments on the proposed rule. All of 
the letters were from biological product manufacturers and 
distributors. All letters favored the proposed rule. Two comments 
requested that the proposed rule be broadened to further harmonize the 
biologics labeling regulations with requirements applicable to drugs 
approved under the act. One comment requested clarification of the 
proposed rule.
    1. One comment requested that FDA completely harmonize Sec. 610.64 
with Sec. 201.1 regarding appearance of the manufacturer's name and 
address. The comment stated that FDA's proposal to retain the 
requirement that the manufacturer's name and address appear on the 
label of a biologic product imposes regulatory burden on manufacturers 
who produce both biological products and drugs approved under the act, 
as there is no such corresponding requirement for drugs subject to 
Sec. 201.1.
    FDA agrees that harmonizing the labeling requirements applicable to 
biological products with those applicable to drugs approved under the 
act is desirable, where appropriate. The PHS Act, section 351(a), 
requires that each package of a biological product subject to licensure 
be plainly marked with the name, address, and license number of the 
manufacturer. The agency believes that the provision in this final rule 
that the manufacturer's name, address, and license number must appear 
on the label of a biological product is a reasonable approach to 
address the statutory requirement. However, as part of the May 14, 1996 
(61 FR 24227), final rule to eliminate the establishment license 
application requirement for specified biotechnology and specified 
synthetic biological products licensed under the PHS Act, FDA has 
broadened the definition of ``manufacturer'' in 21 CFR 600.3(t) to 
provide greater flexibility in determining who may hold a license, and 
consequently, who would be identified as the ``manufacturer'' in 
labeling.
    2. A second comment requested that FDA clarify whether the deletion 
of the requirement that a distributor's name be less prominent than the 
manufacturer's name would apply to promotional labeling.
    While the final rule applies by its terms to the ``label'' on a 
biological product and does not specifically address promotional 
labeling, FDA intends to apply a similar policy in its review of 
promotional labeling.
    3. A third comment asked that consideration be given to allowing 
the product trademark or logo to appear on the labeling in larger type 
than the product name.
    The requirement that the proper name be at least as prominent as 
the trademark and trade name is included in 21 CFR 610.62. Labeling 
requirements other than in Sec. 610.64 are not addressed in this 
rulemaking. In the Federal Register of June 3, 1994 (58 FR 28821), FDA 
announced that it was undertaking the review of the general biologics 
and licensing regulations, including labeling regulations. FDA will 
consider the comment regarding the prominence of the product trademark 
or logo as part of the general review of the regulations.
    FDA has considered all comments received in response to the 
proposed rule and has determined that the proposed rule should be 
issued as a final rule. Accordingly, FDA is issuing as a final rule a 
revised Sec. 610.64 to provide greater flexibility in displaying the 
prominence of the name of a product distributor on the product label.

IV. Effective Date

    The final rule is effective November 18, 1996. As provided under 5 
U.S.C. 553(d) and Sec. 10.40(c)(4) (21 CFR 10.40(c)(4)), the effective 
date of a final rule may not be less than 30 days after date of 
publication, except for, among other things, ``a regulation that grants 
an exemption or relieves a restriction'' (Sec. 10.40(c)(4)(i)). 
Because, as described in section V. of this document, this final rule 
will provide greater flexibility in labeling to manufacturers and 
distributors of biological products, FDA believes that an effective 
date shorter than 30 days is appropriate.

V. Analysis of Impacts

    FDA has examined the impact of the final 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 impact; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    Under the Regulatory Flexibility Act, FDA must analyze regulatory 
options that would minimize any significant economic impact of the rule 
on small entities. This 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. It does not 
require any entity to change its current procedures. At this time FDA 
cannot quantify the benefits of the rule, although it may benefit 
manufacturers or distributors by allowing greater flexibility in 
labeling. Therefore, under the Regulatory Flexibility Act (5 U.S.C. 
605(b)), FDA certifies that this rule will not have a significant 
economic impact on a substantial number of small entities, and no 
further analysis is required.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(c)(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.

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

[[Page 57330]]

delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is 
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, 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 (41 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: October 28, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28530 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F