[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Proposed Rules]
[Pages 4221-4223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2238]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 601, and 606
[Docket No. 96N-0395]
Revision of the Requirements for a Responsible Head for
Biological Establishments
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 biologics regulations by deleting the requirements for a biologics
establishment to name a ``responsible head'' or ``designated qualified
person'' to represent the establishment in its dealings with FDA.
Because many manufacturers of biological products are firms that have
more than one manufacturing location and complex corporate structures,
it may no longer be practical for one individual to represent a
manufacturer in all matters. The proposed rule would provide
manufacturers with more flexibility in assigning control and oversight
responsibility within a company. This proposed rule is part of FDA's
continuing effort to achieve the objectives of the President's
``Reinventing Government'' initiative, and it is intended to reduce the
burden of unnecessary regulations on industry without diminishing
public health protection.
DATES: Comments must be submitted on or before April 29, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Corporations should submit two copies of any
comments and individuals may submit one copy. Comments should be
identified with the docket number found in brackets in the heading of
this document. Received comments are available for public examination
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-594-3074.
SUPPLEMENTARY INFORMATION:
I. Background
Under Sec. 600.10(a) (21 CFR 600.10(a)), a manufacturer of
biological products is required to name a ``responsible head'' who is
to exercise control of the manufacturing establishment in all matters
relating to compliance with regulations in parts 600 through 680 (21
CFR parts 600 through 680) and who is to represent the manufacturer in
all pertinent matters with the Center for Biologics Evaluation and
Research (CBER). This individual must also have an understanding of the
scientific principles and techniques related to the manufacture of
biological products. When FDA announced in the Federal Register of June
3, 1994 (59 FR 28821 and 28822), the review by CBER of certain
biologics regulations to identify those regulations that are outdated,
burdensome, inefficient, duplicative, or otherwise unsuitable or
unnecessary, Sec. 600.10(a) was included. FDA also held a public
meeting on January 26, 1995, to discuss the retrospective review effort
and to provide a forum for the public to voice its comments on the
retrospective review.
Many of the comments submitted requested revision or elimination of
the requirements for a ``responsible head'' in Sec. 600.10(a). The
majority of the comments supported deletion of the regulation. The
comments stated that the requirement for a responsible head to be an
expert in multiple functions and to be responsible for a number of
facility locations is incompatible with current industry practice. The
comments added that the list of activities in Sec. 600.10(a) is
extremely broad and this regulation could be interpreted to require the
responsible head to have an intimate understanding of a wide variety of
extremely complex activities. All of these activities require specific
expertise, and it may not be practical to expect one person to be an
expert in all of those areas. Some comments addressed the requirement
that the responsible head be responsible for training and have the
authority to enforce discipline, stating that direct line supervision
and management personnel are much better qualified and in a better
position to ``enforce or direct the enforcement of discipline and
performance of assigned functions by employees engaged in the
manufacture of products.'' Many comments requested the designation of
an alternate responsible head, especially in the situation of multiple
locations.
As part of the President's ``Reinventing Government'' initiative, a
report entitled ``Reinventing the Regulation of Drugs Made From
Biotechnology'' was issued in November 1995. The report announced
several initiatives to reduce the burden of FDA regulations on the
biologics industry without reducing public health protection, including
a proposal to remove the requirements in Sec. 600.10(a) for a
``responsible head.'' The proposed revision, reflecting comments
submitted in response to the January 26, 1995, public meeting, would
enable firms to designate more than one person to communicate directly
with FDA on official matters related to the biological products they
manufacture. The commitment to remove requirements for a ``responsible
head'' was based on FDA's determination that, with the many changes
that have occurred in science, technology, and corporate structure, it
no longer may be practical for most biologics manufacturers to rely on
one individual to meet the requirements included in Sec. 600.10(a). In
addition, the responsible corporate officer doctrine, e.g., United
States v. Park, 421 U.S. 658 (1975); United States v. Dotterweich, 320
U.S. 277 (1943),
[[Page 4222]]
places the burden of ensuring compliance with the statutes and
regulations applicable to biological products on corporate officials
``standing in responsible relation to a public danger.'' (Dotterweich,
320 U.S. at 281.) Thus, it is not necessary to require manufacturers to
designate a ``responsible head'' in order to enforce the duty
responsible corporate officials have to implement measures to ensure
that violations do not occur. (Park, 421 U.S. at 672.)
In accordance with a recent revision to the definition of
``manufacturer'' in Sec. 600.3 (see 61 FR 24227, May 14, 1996), a
biologics applicant may apply for and obtain a license for a product to
be manufactured at more than one manufacturing site that may or may not
be owned by the applicant. Therefore, firms may want to designate more
than one person with primary responsibility to maintain adequate
oversight of multiple manufacturing sites and ensure that each is
conforming to FDA's requirements for current good manufacturing
practices and the applicable biologics standards. Many biologics
manufacturers also manufacture drugs that are regulated by the Center
for Drug Evaluation and Research (CDER) under the Federal Food, Drug,
and Cosmetic Act whose regulations do not contain an analogous
requirement for the responsible head. FDA's proposal to revise the
requirements with respect to a responsible head is an effort to
harmonize CBER's and CDER's policies and requirements and to keep pace
with changes in science, technology, and corporate structure.
II. Proposed Rule
Under the proposed revision, an authorized official would be
chosen by the applicant to receive and send correspondence to CBER. The
applicant could choose to have more than one authorized official.
Accordingly, the agency proposes to amend Sec. 600.10 by removing and
reserving paragraph (a) and revising the heading of paragraph (b) to
read ``Personnel''. The agency also proposes to amend Sec. 601.2
Applications for establishment and product licenses; procedures for
filing by adding the statement ``The applicant, or the applicant's
attorney, agent, or other authorized official shall sign the
application'' in paragraph (a) and new paragraph (c)(6). Finally, the
agency proposes to amend Sec. 601.25(b)(3)(VIII) by replacing ``signed
by the responsible head (as defined in Sec. 600.10 of this chapter of
the licensee)'' with ``signed by an authorized official of the
licensee''.
FDA is also proposing to remove Sec. 606.20(a), which contains
language similar to that in Sec. 600.10(a) and applies to all blood
establishments, including registered, unlicensed blood establishments.
Like other components of the biologics industry, the blood industry has
experienced changes in science, technology, and corporate structure.
Complex donor and transfusion recipient issues, the evolution of
sophisticated computerized laboratory and donor equipment, complicated
serology problems, and state-of-the-art laboratory techniques have all
contributed to changes within the structure of blood establishments,
regardless of size. To ensure the quality and safety of the blood
supply, many blood establishments employ personnel who are experts in
donor issues, infectious disease, computers, molecular biology,
serology, transfusion issues, quality control, administration, and
management. It is no longer practical to expect one individual to have
expertise in all the subspecialties of transfusion medicine.
Accordingly, to provide sufficient flexibility for a blood
establishment to select a person with appropriate training and
experience to be responsible for each facet of its operation, the
agency proposes to remove and reserve Sec. 606.20(a).
FDA intends that a final rule would become effective as soon as
possible after publication in the Federal Register.
III. Economic Impact
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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.
Under the Regulatory Flexibility Act, if a rule has a significant
impact on a substantial number of small entities, an agency must
analyze regulatory options that would minimize any significant impact
of a rule on small entities. The proposed rule would have no compliance
costs and would not result in any new requirements. Therefore, under
the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commissioner of
Food and Drugs certifies that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
No further analysis is required.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
Interested persons may, on or before April 29, 1997, 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.
List of Subjects
21 CFR Part 600
Biologics, Reporting and recordkeeping requirements.
21 CFR Part 601
Administrative practice and procedure, Biologics, Confidential
business information.
21 CFR Part 606
Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 600,
601, and 606 be amended as follows:
PART 600--BIOLOGICAL PRODUCTS: GENERAL
1. The authority citation for 21 CFR part 600 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 519, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352,
353, 355, 360, 360i, 371, 374); secs. 215, 351, 352, 353, 361, 2125
of the Public Health Service Act (42 U.S.C. 216, 262, 263, 263a,
264, 300aa-25).
Sec. 600.10 [Amended]
2. Section 600.10 Personnel is amended by removing and reserving
[[Page 4223]]
paragraph (a) and by revising the heading of paragraph (b) to read
``Personnel.''
PART 601--LICENSING
3. The authority citation for 21 CFR part 601 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 513-516, 518-520,
701, 704, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 374,
379e, 381); secs. 215, 301, 351, 352 of the Public Health Service
Act (42 U.S.C. 216, 241, 262, 263); secs. 2-12 of the Fair Packaging
and Labeling Act (15 U.S.C. 1451-1461).
4. Section 601.2 is amended by adding a sentence before the last
sentence in paragraph (a), and by adding new paragraph (c)(6) to read
as follows:
Sec. 601.2 Applications for establishment and product licenses;
procedures for filing.
(a) * * * The applicant, or the applicant's attorney, agent, or
other authorized official shall sign the application. * * *
* * * * *
(c) * * *
(6) The applicant, or the applicant's attorney, agent, or other
authorized official shall sign the application.
5. Section 601.25 is amended by revising the first sentence of
paragraph (b)(3)(VIII) to read as follows:
Sec. 601.25 Review procedures to determine that licensed biological
products are safe, effective, and not misbranded under prescribed,
recommended, or suggested conditions of use.
* * * * *
(b) * * *
(3) * * *
(VIII) If the submission is by a licensee, a statement signed by
an authorized official of the licensee shall be included, stating
that to the best of his or her knowledge and belief, it includes all
information, favorable and unfavorable, pertinent to an evaluation
of the safety, effectiveness, and labeling of the product, including
information derived from investigation, commercial marketing, or
published literature. * * *
* * * * *
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
6. The authority citation for 21 CFR part 606 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 505, 510, 520, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,
352, 355, 360, 360j, 371, 374); secs. 215, 351, 353, 361 of the
Public Health Service Act (42 U.S.C. 216, 262, 263a, 264).
Sec. 606.20 [Amended]
7. Section 606.20 Personnel is amended by removing and reserving
paragraph (a).
Dated: January 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-2238 Filed 1-28-97; 8:45 am]
BILLING CODE 4160-01-F