Agency Information Collection Activities; Proposed Collection; Comment Request; Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition, 9829-9830 [E6-2727]
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9829
Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
FDA Center
No. of
Focus
Groups per
Study
Subject
Total
28
1There
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0080]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Aluminum in Large
and Small Volume Parenterals Used in
Total Parenteral Nutrition
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the labeling requirements for aluminum
content in large volume parenterals
(LVPs), small volume parenterals
(SVPs), and pharmacy bulk packages
(PBPs) used in total parenteral nutrition
(TPN).
DATES: Submit written or electronic
comments on the collection of
information by April 28, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
VerDate Aug<31>2005
14:15 Feb 24, 2006
Jkt 208001
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
hsrobinson on PROD1PC70 with NOTICES
286
Hours of
Duration for
Each Group
(Includes
Screening)
Total Hours
1.78
No. of
Participants
per Group
4,252
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–2726 Filed 2–24–06; 8:45 am]
ACTION:
No. of
Focus
Groups
Sessions
Conducted
Annually
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Aluminum in Large and Small Volume
Parenterals Used in Total Parenteral
Nutrition—21 CFR 201.323 (OMB
Control Number 0910–0439)—Extension
FDA is requesting OMB approval
under the PRA for the labeling
requirements for aluminum content in
LVPs, SVPs, and PBPs used in TPN. As
explained in the final rule on aluminum
content labeling requirements published
in the Federal Register of January 26,
2000 (65 FR 4103) (the January 2000,
final rule), aluminum content in
parenteral drug products could result in
a toxic accumulation of aluminum in
the tissues of individuals receiving TPN
therapy. Research indicates that
neonates and patient populations with
impaired kidney function may be at
high risk of exposure to unsafe amounts
of aluminum. Studies show that
aluminum may accumulate in the bone,
urine, and plasma of infants receiving
TPN. Many drug products used
routinely in parenteral therapy may
contain levels of aluminum sufficiently
high to cause clinical manifestations.
Generally, when medication and
nutrition are administered orally, the
gastrointestinal tract acts as an efficient
barrier to the absorption of aluminum,
and relatively little ingested aluminum
actually reaches body tissues. However,
parenterally administered drug products
containing aluminum bypass the
protective mechanism of the
gastrointestinal tract, and aluminum
circulates and is deposited in human
tissues.
Aluminum toxicity is difficult to
identify in infants because few reliable
techniques are available to evaluate
bone metabolism in premature infants.
Techniques used to evaluate the effects
of aluminum on bone in adults cannot
be used in premature infants. Although
aluminum toxicity is not commonly
detected clinically, it can be serious in
selected patient populations, such as
neonates, and may be more common
than is recognized.
FDA amended its regulations to add
labeling requirements for aluminum
content in LVPs, SVPs, and PBPs used
in TPN. FDA specified an upper limit of
aluminum permitted in LVPs and
E:\FR\FM\27FEN1.SGM
27FEN1
9830
Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices
required applicants to submit to FDA
validated assay methods for determining
aluminum content in parenteral drug
products. The agency added these
requirements because of evidence
linking the use of parenteral drug
products containing aluminum to
morbidity and mortality among patients
on TPN therapy, especially among
premature neonates and patients with
impaired kidney function.
The information collection reporting
requirements are as follows:
Section 201.323(b) (21 CFR
201.323(b)) requires that the package
insert of all large volume parenterals
used in total parenteral nutrition
therapy state that the drug product
contains no more than 25 micrograms
(µg)/liter (L). This information must be
contained in the ‘‘Precautions’’ section
of the labeling of all LVPs used in TPN
therapy.
Section 201.323(c) (21 CFR
201.323(c)) requires that the maximum
level of aluminum present at expiry be
stated on the immediate container label
of all SVP drug products and PBPs used
in the preparation of TPN solutions. The
aluminum content must be stated as
prescribed in the regulation. The
immediate container label of all SVP
drug products and PBPs that are
lyophilized powders used in the
preparation of TPN solutions must
contain the statement prescribed in the
regulation.
Section 201.323(d) (21 CFR
201.323(d)) requires that the package
insert for all LVPs, SVPs, and PBPs used
in TPN contain a warning statement,
prescribed in the regulation, intended
for patients with impaired kidney
function and for neonates receiving TPN
therapy. This information must be
contained in the ‘‘Warnings’’ section of
the labeling.
Section 201.323(e) (21 CFR
201.323(e)) requires that applicants and
manufacturers must use validated assay
methods to determine the aluminum
content in parenteral drug products. The
assay methods must comply with
current good manufacturing practice
requirements. Applicants must submit
to FDA both validation of the method
used and release data for several
batches. Manufacturers of parenteral
drug products not subject to an
approved application must make assay
methodology available to FDA during
inspections. Holders of pending
applications must submit an
amendment to the application.
Compliance with the information
collection burdens under § 201.323(b),
(c), and (d) consists of submitting
application supplements to FDA
containing the revised labeling for each
product, and analytical method
validation must be submitted under
§ 201.323(e). During the period since the
publication of the January 2000, final
rule, FDA has received approximately
100 supplements and analytical method
validation from approximately four
respondents. Because the final rule was
effective on July 26, 2004, FDA expects
to receive fewer submissions per year.
FDA estimates that it will take
approximately 14 hours to prepare and
submit to FDA each submission.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
201.323(b),(c),(d)
4
1.25
5
14
70
201.323(e)
4
1.25
5
14
70
Total
1There
140
are no capital costs or operating and maintenance costs associated with this collection.
Dated: February 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–2727 Filed 2–24–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Open Meeting of the Federal
Interagency Committee on Emergency
Medical Services (FICEMS)
Federal Emergency
Management Agency (FEMA),
Department of Homeland Security.
ACTION: Notice of open meeting.
hsrobinson on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: FEMA announces the
following open meeting.
Name: Federal Interagency Committee
on Emergency Medical Services
(FICEMS).
Date of Meeting: March 2, 2006.
VerDate Aug<31>2005
14:15 Feb 24, 2006
Jkt 208001
Place: 10th Floor MacCracken Room,
FAA Building, 800 Independence Ave
SW., Washington, DC 20591.
Times: 10:30 a.m.—Main FICEMS
Meeting; 1 p.m.—FICEMS Ambulance
Safety Subcommittee.
Proposed Agenda: Review and
submission for approval of previous
FICEMS Committee Meeting Minutes;
Ambulance Safety Subcommittee
Meeting Minutes; Action Items review;
presentation of member agency reports;
and reports of other interested parties.
SUPPLEMENTARY INFORMATION: This
meeting will be open to the public with
limited seating available on a first-come,
first-served basis. See the Response and
Security Procedures below.
Response Procedures: Committee
Members and members of the general
public who plan to attend the meeting
should contact Mr. Mike McKay, on or
before Tuesday, February 28, 2006, via
mail at NATEK Incorporated, 21355
Ridgetop Circle, Suite 200, Dulles,
Virginia 20166–8503, or by telephone at
(703) 674–0190, or via facsimile at (703)
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
674–0195, or via e-mail at
mmckay@natekinc.com. This is
necessary to be able to create and
provide a current roster of visitors to
FAA Security per directives.
Security Procedures: All visitors must
have a valid picture identification card
and their vehicles will be subject to
search by Security personnel. All
visitors will be issued a visitor pass
which must be worn at all times while
in the facility. Please allow adequate
time before the meeting to complete the
security process.
Conference Call Capabilities: If you
are not able to attend in person, a toll
free number has been set up for
teleconferencing. The toll free number
will be available from 10 a.m. until 4
p.m. Members should call in around
10:30 a.m. The number is 1–800–320–
4330. The FICEMS conference code is
‘‘361352#,’’ which is different.
FICEMS Meeting Minutes: Minutes of
the meeting will be prepared and will be
available upon request 30 days after
they have been approved at the next
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 71, Number 38 (Monday, February 27, 2006)]
[Notices]
[Pages 9829-9830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0080]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Aluminum in Large and Small Volume Parenterals Used in
Total Parenteral Nutrition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the labeling requirements for
aluminum content in large volume parenterals (LVPs), small volume
parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total
parenteral nutrition (TPN).
DATES: Submit written or electronic comments on the collection of
information by April 28, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Aluminum in Large and Small Volume Parenterals Used in Total Parenteral
Nutrition--21 CFR 201.323 (OMB Control Number 0910-0439)--Extension
FDA is requesting OMB approval under the PRA for the labeling
requirements for aluminum content in LVPs, SVPs, and PBPs used in TPN.
As explained in the final rule on aluminum content labeling
requirements published in the Federal Register of January 26, 2000 (65
FR 4103) (the January 2000, final rule), aluminum content in parenteral
drug products could result in a toxic accumulation of aluminum in the
tissues of individuals receiving TPN therapy. Research indicates that
neonates and patient populations with impaired kidney function may be
at high risk of exposure to unsafe amounts of aluminum. Studies show
that aluminum may accumulate in the bone, urine, and plasma of infants
receiving TPN. Many drug products used routinely in parenteral therapy
may contain levels of aluminum sufficiently high to cause clinical
manifestations. Generally, when medication and nutrition are
administered orally, the gastrointestinal tract acts as an efficient
barrier to the absorption of aluminum, and relatively little ingested
aluminum actually reaches body tissues. However, parenterally
administered drug products containing aluminum bypass the protective
mechanism of the gastrointestinal tract, and aluminum circulates and is
deposited in human tissues.
Aluminum toxicity is difficult to identify in infants because few
reliable techniques are available to evaluate bone metabolism in
premature infants. Techniques used to evaluate the effects of aluminum
on bone in adults cannot be used in premature infants. Although
aluminum toxicity is not commonly detected clinically, it can be
serious in selected patient populations, such as neonates, and may be
more common than is recognized.
FDA amended its regulations to add labeling requirements for
aluminum content in LVPs, SVPs, and PBPs used in TPN. FDA specified an
upper limit of aluminum permitted in LVPs and
[[Page 9830]]
required applicants to submit to FDA validated assay methods for
determining aluminum content in parenteral drug products. The agency
added these requirements because of evidence linking the use of
parenteral drug products containing aluminum to morbidity and mortality
among patients on TPN therapy, especially among premature neonates and
patients with impaired kidney function.
The information collection reporting requirements are as follows:
Section 201.323(b) (21 CFR 201.323(b)) requires that the package
insert of all large volume parenterals used in total parenteral
nutrition therapy state that the drug product contains no more than 25
micrograms (microg)/liter (L). This information must be contained in
the ``Precautions'' section of the labeling of all LVPs used in TPN
therapy.
Section 201.323(c) (21 CFR 201.323(c)) requires that the maximum
level of aluminum present at expiry be stated on the immediate
container label of all SVP drug products and PBPs used in the
preparation of TPN solutions. The aluminum content must be stated as
prescribed in the regulation. The immediate container label of all SVP
drug products and PBPs that are lyophilized powders used in the
preparation of TPN solutions must contain the statement prescribed in
the regulation.
Section 201.323(d) (21 CFR 201.323(d)) requires that the package
insert for all LVPs, SVPs, and PBPs used in TPN contain a warning
statement, prescribed in the regulation, intended for patients with
impaired kidney function and for neonates receiving TPN therapy. This
information must be contained in the ``Warnings'' section of the
labeling.
Section 201.323(e) (21 CFR 201.323(e)) requires that applicants and
manufacturers must use validated assay methods to determine the
aluminum content in parenteral drug products. The assay methods must
comply with current good manufacturing practice requirements.
Applicants must submit to FDA both validation of the method used and
release data for several batches. Manufacturers of parenteral drug
products not subject to an approved application must make assay
methodology available to FDA during inspections. Holders of pending
applications must submit an amendment to the application.
Compliance with the information collection burdens under Sec.
201.323(b), (c), and (d) consists of submitting application supplements
to FDA containing the revised labeling for each product, and analytical
method validation must be submitted under Sec. 201.323(e). During the
period since the publication of the January 2000, final rule, FDA has
received approximately 100 supplements and analytical method validation
from approximately four respondents. Because the final rule was
effective on July 26, 2004, FDA expects to receive fewer submissions
per year. FDA estimates that it will take approximately 14 hours to
prepare and submit to FDA each submission.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
201.323(b),(c),(d) 4 1.25 5 14 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
201.323(e) 4 1.25 5 14 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 140
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection.
Dated: February 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2727 Filed 2-24-06; 8:45 am]
BILLING CODE 4160-01-S
