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, 66108-66109 [E6-18892]
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66108
Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Rules and Regulations
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701,
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We have determined that this AD will
not have federalism implications under
Executive Order 13132. This AD will
not have a substantial direct effect 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.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
(3) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this AD and placed it in the AD docket.
See the ADDRESSES section for a location
to examine the regulatory evaluation.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
I
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40113, 44701.
cprice-sewell on PROD1PC66 with RULES
§ 39.13
[Amended]
2. The Federal Aviation
Administration (FAA) amends § 39.13
by adding the following new
airworthiness directive (AD):
I
2006–23–13 BAE Systems (Operations)
Limited (Formerly British Aerospace
VerDate Aug<31>2005
15:06 Nov 09, 2006
Jkt 211001
Regional Aircraft): Amendment 39–
14825. Docket No. FAA–2006–25337;
Directorate Identifier 2006–NM–138–AD.
Effective Date
(a) This AD becomes effective December
18, 2006.
Affected ADs
(b) None.
Applicability
(c) This AD applies to all BAE Systems
(Operations) Limited Model BAe 146–100A,
–200A, and –300A series airplanes,
certificated in any category.
Unsafe Condition
(d) This AD results from reports of threephase circuit breakers overheating on inservice airplanes. We are issuing this AD to
prevent failure of a three-phase circuit
breaker. Such failure could prevent an
electrical load from being isolated from its
electrical supply, which could result in
smoke or fire in the flight deck.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified, unless the
actions have already been done.
Detailed Inspection and Corrective Actions
(f) Within 12 months after the effective
date of this AD, do a detailed inspection of
the three-phase circuit breakers and threephase circuit breaker panels for discrepancies
(including but not limited to physical
damage, cracks, deterioration, corrosion,
discoloration, contamination by foreign
objects, and missing or improperly installed
terminal connections or attachments), in
accordance with the Accomplishment
Instructions of BAE Systems (Operations)
Limited Inspection Service Bulletin ISB.24–
141, dated August 15, 2005. If any
discrepancy is found, before further flight, fix
the discrepancy and replace unserviceable
units with new units, as applicable, in
accordance with the inspection service
bulletin.
Note 1: For the purposes of this AD, a
detailed inspection is: ‘‘An intensive
examination of a specific item, installation,
or assembly to detect damage, failure, or
irregularity. Available lighting is normally
supplemented with a direct source of good
lighting at an intensity deemed appropriate.
Inspection aids such as mirror, magnifying
lenses, etc., may be necessary. Surface
cleaning and elaborate procedures may be
required.’’
No Reporting
(g) Although the inspection service bulletin
referenced in this AD specifies to submit
certain information to the manufacturer, this
AD does not include that requirement.
Alternative Methods of Compliance
(AMOCs)
(h)(1) The Manager, International Branch,
ANM–116, Transport Airplane Directorate,
FAA, has the authority to approve AMOCs
for this AD, if requested in accordance with
the procedures found in 14 CFR 39.19.
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Frm 00016
Fmt 4700
Sfmt 4700
(2) Before using any AMOC approved in
accordance with § 39.19 on any airplane to
which the AMOC applies, notify the
appropriate principal inspector in the FAA
Flight Standards Certificate Holding District
Office.
Related Information
(i) The European Aviation Safety Agency
airworthiness directive 2006–0132, dated
May 18, 2006, also addresses the subject of
this AD.
Material Incorporated by Reference
(j) You must use BAE Systems (Operations)
Limited Inspection Service Bulletin ISB.24–
141, dated August 15, 2005, to perform the
actions that are required by this AD, unless
the AD specifies otherwise. The Director of
the Federal Register approved the
incorporation by reference of this document
in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Contact British Aerospace Regional
Aircraft American Support, 13850 Mclearen
Road, Herndon, Virginia 20171, for a copy of
this service information. You may review
copies at the Docket Management Facility,
U.S. Department of Transportation, 400
Seventh Street, SW., Room PL–401, Nassif
Building, Washington, DC; on the Internet at
https://dms.dot.gov; or at the National
Archives and Records Administration
(NARA). For information on the availability
of this material at the NARA, call (202) 741–
6030, or go to https://www.archives.gov/
federal_register/code_of_federal_regulations/
ibr_locations.html.
Issued in Renton, Washington, on October
31, 2006.
Kalene C. Yanamura,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E6–18966 Filed 11–9–06; 8:45 am]
BILLING CODE 4910–13–P
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.
SUMMARY: The Food and Drug
Administration (FDA) is further
delaying, until December 1, 2008, the
applicability date of a certain
E:\FR\FM\13NOR1.SGM
13NOR1
cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 71, No. 218 / Monday, November 13, 2006 / Rules and Regulations
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
§ 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
§ 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 Sanchez, 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
VerDate Aug<31>2005
15:06 Nov 09, 2006
Jkt 211001
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 § 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 § 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 § 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 § 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 § 203.3(q) to the
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
66109
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 § 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]
BILLING CODE 4160–01–S
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13NOR1
]]>Agencies
[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Rules and Regulations]
[Pages 66108-66109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18892]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-S
