[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
