[Federal Register Volume 68, Number 120 (Monday, June 23, 2003)]
[Rules and Regulations]
[Pages 37075-37077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. 2003N-0235]


Assignment of Agency Component for Review of Premarket 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising its 
regulations concerning FDA's procedures for determining which component 
within FDA will have primary jurisdiction for the premarket review and 
regulation of a product composed of a combination of a drug, device, or 
biological product; or any drug, device, or biological product where 
the agency component with jurisdiction is unclear or in dispute. FDA is 
taking this action to implement the requirement of the Medical Device 
User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) 
that FDA establish an office within FDA's Office of the Commissioner to 
ensure the prompt assignment of combination products to agency centers.

DATES: This rule is effective June 23, 2003.

FOR FURTHER INFORMATION CONTACT: Mark D. Kramer, Office of Combination 
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch 
Way, suite 200, Rockville, MD 20855, 301-827-9229, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    A combination product is a product containing a combination of a 
drug, a device, or a biological product. The Safe Medical Devices Act 
of 1990 (Public Law 101-629) added new section 503(g) (21 U.S.C. 
353(g)) to the Federal Food, Drug, and Cosmetic Act (the act)), 
relating to combination products. This section requires that the agency 
assign a component of FDA to have primary jurisdiction for the 
premarket review and regulation of a product that constitutes a 
combination of a drug, device, or biological product. It further 
requires FDA to make this assignment based upon a determination of the 
primary mode of action of the combination product. In the Federal 
Register of November 21, 1991 (56 FR 58754), FDA issued a final rule 
establishing the procedures for implementing section 503(g) in part 3 
(21 CFR part 3).
    MDUFMA amended section 503(g) of the act to require that FDA 
establish within its Office of the Commissioner an office to ensure: 
(1) The prompt assignment of combination products to agency centers, 
(2) the timely and effective premarket review of such products, and (3) 
consistent and appropriate postmarket regulation of like products 
subject to the same statutory requirements to the extent permitted by 
law. New section 503(g)(4) further states that, in carrying out its 
duties, this office shall:
    [sbull] Promptly assign an agency center with primary jurisdiction 
for the premarket review of the product. The office, in determining 
whether a product

[[Page 37076]]

is appropriately classified as a combination product, shall consult 
with the component within the Office of the Commissioner that is 
responsible for such determinations;
    [sbull] Ensure timely and effective premarket reviews by overseeing 
the timeliness of and coordinating reviews involving more than one 
agency center;
    [sbull] Ensure the consistency and appropriateness of postmarket 
regulation of like products subject to the same statutory requirements 
to the extent permitted by law;
    [sbull] Address any dispute regarding the timeliness of the 
premarket review of a combination product, unless the dispute is 
clearly premature.
    New section 503(g)(4)(F) of the act also directs the Secretary of 
Health and Human Services, through the new office, to review each 
agreement, guidance, or practice specific to the assignment of 
combination products to agency centers and to report annually to the 
appropriate committees of Congress on the activities and impact of the 
office.
    On December 24, 2002, FDA established the Office of Combination 
Products to carry out the responsibilities under section 503(g) of the 
act and to perform other activities related to combination products. 
More information about the office is available at http://www.fda.gov/oc/combination/.
    To enhance the efficiency of agency operations, the Office of 
Combination Products is assuming responsibility from the Office of the 
Ombudsman for designating the component of FDA with primary 
jurisdiction for the premarket review and regulation of any product 
requiring a jurisdictional designation under this part. Such decisions 
may involve determinations of: (1) The regulatory identity of a product 
as a drug, device, biologic, or combination product; (2) the agency 
component that will have jurisdiction for any drug, device, or 
biological product where such jurisdiction is unclear or in dispute; 
and (3) the primary mode of action and assignment of a lead center for 
a combination product. The act requires the office, in determining 
whether a product is appropriately classified as a combination product, 
to consult with the component within the Office of the Commissioner 
that is responsible for such determinations. Since the Office of the 
Commissioner has now assigned to the Office of Combination Products the 
responsibility for such determinations, no separate consultation is 
necessary.

II. Summary of the Final Rule

    FDA is making the following changes to part 3 to establish rules of 
agency organization, procedure, and practice, that are consistent with 
new section 503(g)(4) of the act and are otherwise clear and 
appropriate:
    (1) FDA is amending Sec.  3.1 to cite MDUFMA as an additional 
authority.
    (2) FDA is amending Sec.  3.2 to modify the definition of ``agency 
component'' to be consistent with definition of ``agency center'' 
provided in MDUFMA.
    (3) FDA is amending Sec.  3.6 to identify the Office of Combination 
Products as the agency's product jurisdiction officer.
    (4) FDA is amending Sec.  3.7 to provide information related to the 
submission of electronic copies of requests for designation concurrent 
with the submission of the official request.
    (5) FDA is amending Sec.  3.9 to reflect that a nonconsensual 
change in the designated agency component requires the concurrence of 
the Principal Associate Commissioner. This change reflects the current 
organizational structure of FDA's Office of the Commissioner.

III. Authority for Issuing Final Rule

    This rule provides an administrative mechanism to determine which 
agency component has responsibility for the review of an application. 
The agency determined that this is ``a matter relating to agency 
management'' and a rule of ``agency organization, procedure, or 
practice'' and, as such, is exempt from notice and comment under the 
Administrative Procedure Act (5 U.S.C. 553(a)(2) and (b)(A)). FDA also 
finds good cause under 5 U.S.C. 553(b)(B) and Sec.  10.40(e) (21 CFR 
10.40(e)) to forego notice and comment as it would be unnecessary and 
contrary to the public interest to delay implementation of this rule. 
As provided under FDA's administrative practices and procedures 
regulation (Sec.  10.40(e)), FDA is providing an opportunity for public 
comment on whether the regulation should be modified or revoked.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this rule 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.

V. Analysis of Impacts

    Because this is a rule of agency organization, procedure, practice, 
and management that is issued as a final rule, and not as a proposed 
rule, the requirements of Executive Order 12866 and the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (Public Law 104-4) do not apply. However, FDA has examined 
the impacts of this final rule under those provisions. 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 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. When applicable, 
the Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. This rule is merely procedural in nature and imposes no new 
burdens on small entities. Indeed, the purpose of the procedures 
embodied in this rule is to expedite the review of combination 
products, and this final rule will not have a significant economic 
impact on a substantial number of small entities. Finally, a summary 
statement or analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is required only for nonprocedural rules that impose 
costs of $110 million or more on either the private sector or state, 
local, and tribal governments in the aggregate. This rule imposes no 
such costs.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that this final rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by

[[Page 37077]]

OMB under Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 3

    Administrative practice and procedure, Biologics, Drugs, Medical 
devices.

0
Therefore, under the Federal , Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
3 is amended as follows:

PART 3--PRODUCT JURISDICTION

    1. The authority citation for 21 CFR part 3 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 360gg-360ss, 371(a), 379(e), 381, 394; 42 U.S.C. 216, 
262.

0
2. Section 3.1 is amended by revising the second sentence to read as 
follows:


Sec.  3.1  Purpose.

    * * * The first is to implement section 503(g) of the act, as added 
by section 16 of the Safe Medical Devices Act of 1990 (Public Law 101-
629) and amended by section 204 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250), by specifying how FDA 
will determine the organizational component within FDA designated to 
have primary jurisdiction for the premarket review and regulation of 
products that are comprised of any combination of a drug and a device; 
a device and a biological; a biological and a drug; or a drug, a device 
and a biological.* * *

0
3. Section 3.2 is amended by revising paragraph (b) to read as follows:


Sec.  3.2  Definitions.

* * * * *
    (b) Agency component means the Center for Biologics Evaluation and 
Research, the Center for Devices and Radiological Health, the Center 
for Drug Evaluation and Research, or alternative organizational 
component of the agency.
* * * * *

0
4. Section 3.6 is revised to read as follows:


Sec.  3.6  Product jurisdiction officer.

    The Office of Combination Products (HFG-3), Food and Drug 
Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 
20855, 301-827-9229, e-mail: [email protected], is the designated 
product jurisdiction officer.

0
5. Section 3.7 is amended by adding a sentence to the end of paragraph 
(d) to read as follows:


Sec.  3.7  Request for designation.

* * * * *
    (d) * * *Concurrent submissions of electronic copies of Requests 
for Designation may be addressed to [email protected].

0
6. Section 3.9 is amended by revising the last sentence of paragraph 
(b) to read as follows:


Sec.  3.9  Effect of letter of designation.

* * * * *
    (b) * * * A nonconsensual change in the designated agency component 
requires the concurrence of the Principal Associate Commissioner.

    Dated: June 13, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15698 Filed 6-20-03; 8:45 am]
BILLING CODE 4160-01-S