[Printable PDF]
[Federal Register: November 13, 2006 (Volume 71, Number 218)]
[Rules and Regulations]
[Page 66108-66109]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no06-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 203
[Docket No. 1992N-0297 (formerly 92N-0297)]
RIN 0905-AC81
Distribution of Blood Derivatives by Registered Blood
Establishments That Qualify as Health Care Entities; Prescription Drug
Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of
Applicability Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of applicability date.
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SUMMARY: The Food and Drug Administration (FDA) is further delaying,
until December 1, 2008, the applicability date of a certain
[[Page 66109]]
requirement of a final rule published in the Federal Register of
December 3, 1999 (64 FR 67720) (the final rule). The final rule
implements the Prescription Drug Marketing Act of 1987 (PDMA), as
modified by the Prescription Drug Amendments of 1992 (PDA), and the
Food and Drug Administration Modernization Act of 1997 (the
Modernization Act). The provisions of the final rule became effective
on December 4, 2000, except for certain provisions whose effective or
applicability dates were delayed in five subsequent Federal Register
notices, until December 1, 2006. The provision with the delayed
applicability date would prohibit wholesale distribution of blood
derivatives by registered blood establishments that meet the definition
of a ``health care entity.'' In the Federal Register of February 1,
2006 (71 FR 5200), FDA published a proposed rule specific to the
distribution of blood derivatives by registered blood establishments
that qualify as health care entities (the proposed rule). The proposed
rule would amend certain limited provisions of the final rule to allow
certain registered blood establishments that qualify as health care
entities to distribute blood derivatives. In response to the proposed
rule, FDA received substantive comments.
As explained in the SUPPLEMENTARY INFORMATION section of this
document, further delaying the applicability of Sec. 203.3(q) (21 CFR
203.3(q)) to the wholesale distribution of blood derivatives by health
care entities is necessary to give the agency additional time to
address comments on the proposed rule, consider whether regulatory
changes are appropriate, and, if so, to initiate such changes.
DATES: The applicability date for Sec. 203.3(q) to the wholesale
distribution of blood derivatives by health care entities is delayed
until December 1, 2008.
FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: The PDMA (Pub. L. 100-293) was enacted on
April 22, 1988, and was modified by the PDA (Pub. L. 102-353, 106 Stat.
941) on August 26, 1992. The PDMA, as modified, amended the Federal
Food, Drug, and Cosmetic Act (the act) to, among other things,
prohibit, with certain exceptions, the sale, purchase, or trade (or
offer to sell, purchase, or trade) of prescription drugs that were
purchased by hospitals or other health care entities (section
503(c)(3)(A)(ii)(I) of the act (21 U.S.C. 353(c)(3)(A)(ii)(I))).
Section 503(c)(3) of the act also states that ``[f]or purposes of this
paragraph, the term `entity' does not include a wholesale distributor
of drugs or a retail pharmacy licensed under State law * * *.''
On December 3, 1999, the agency published final regulations in part
203 (21 CFR part 203) implementing PDMA (64 FR 67720) that were to take
effect on December 4, 2000. Most of the provisions of the final rule
took effect on this date. Certain provisions of the final rule,
including Sec. 203.3(q) which defines the term ``health care entity,''
were delayed on account of concerns raised by the affected parties. The
agency received several letters on, and held several meetings to
discuss, the implications of the final rule for blood centers that
distribute blood derivative products and provide health care to
hospitals and patients. Under the final rule as written, blood
establishments functioning as health care entities would not be allowed
to engage in wholesale distribution of prescription drugs except for
blood and blood components intended for transfusion, which are exempted
from the regulations under Sec. 203.1. As discussed in the preamble to
the final rule (64 FR 67720 at 67725 to 67727), blood derivatives are
not blood components. Therefore, under the final rule as written,
registered blood establishments that qualify as health care entities
could not distribute blood derivatives. Based on comments from
interested parties, FDA decided to delay the applicability of Sec.
203.3(q), until October 1, 2001, and reopened the administrative record
to give interested persons until July 3, 2000, to submit written
comments on this provision (65 FR 25639, May 3, 2000).
FDA has delayed the applicability date of Sec. 203.3(q) four more
times, most recently until December 1, 2006. On these occasions, the
applicability date was delayed to give the agency time to consider
whether regulatory changes were warranted (66 FR 12850, March 1, 2001;
67 FR 6645, February 13, 2002; 68 FR 4912, January 31, 2003; 69 FR
8105, February 23, 2004). In the Federal Register of February 1, 2006
(71 FR 5200), FDA issued a proposed rule that would amend the final
rule to allow certain registered blood establishments that qualify as
health care entities to distribute blood derivatives. FDA has received
substantive comments on the proposed rule from affected parties. Today,
FDA is further delaying the applicability of Sec. 203.3(q) to the
wholesale distribution of blood derivatives by health care entities to
give FDA additional time to address comments on the proposed rule and
consider the appropriate regulatory changes.
FDA has examined the impacts of this delay of the applicability
date under Executive Order 12866. 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 action
is consistent with the regulatory philosophy and principles identified
in the Executive order. This action will ease the burden on industry by
delaying the applicability of Sec. 203.3(q) to the wholesale
distribution of blood derivatives by health care entities while FDA
continues to address comments on the proposed rule and consider
regulatory changes. Thus, this action is not a significant action as
defined by the Executive order.
To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). Alternatively, the agency's
implementation of this action without opportunity for public comment,
effective immediately upon publication today in the Federal Register,
is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3).
Seeking public comment is impracticable, unnecessary, and contrary to
the public interest. Given the imminence of the current December 1,
2006, compliance date, seeking prior public comment on this delay is
contrary to the public interest in the orderly issuance and
implementation of regulations.
This action is being taken under FDA's authority under 21 CFR
10.35(a). The Commissioner of Food and Drugs finds that this delay of
the applicability date is in the public interest.
Dated: October 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18892 Filed 11-9-06; 8:45 am]
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