[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Rules and Regulations]
[Pages 66108-66109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18892]


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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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