Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration, 9828-9829 [E6-2726]
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9828
Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices
Dated: February 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–2710 Filed 2–24–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0443]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 29,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Focus Groups as Used by the Food and
Drug Administration—(OMB Control
Number 0910–0497)—Extension
FDA will collect and use information
gathered through the focus group
vehicle. This information will be used
to develop programmatic proposals, and
as such, compliments other important
research findings to develop these
proposals. Focus groups do provide an
important role in gathering information
because they allow for a more in-depth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies.
Also, information from these focus
groups will be used to develop policy
and redirect resources, when necessary,
to our constituents. If this information is
not collected, a vital link in information
gathering by FDA to develop policy and
programmatic proposals will be missed
causing further delays in policy and
program development.
In the Federal Register of November
25, 2005 (FR 70 71165), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. FDA received one comment,
however it was not related to the
information collection.
Annually, FDA projects about 28
focus group studies using 286 focus
groups lasting an average of 1.78 hours
each. FDA has allowed burden for
unplanned focus groups to be
completed so as not to restrict the
agency’s ability to gather information on
public sentiment for its proposals in its
regulatory as well as other programs. To
arrive at each center’s estimated burden
we multiplied the number of focus
groups per study by the number of
participants per group. (e.g., Center for
Biologics Evaluation and Research
(CBER): 5x9=45). We multiplied that
total by the hours of duration for each
group to arrive at the total burden hours.
(e.g., CBER: 45x1.58=71.1).
The total annual estimated burden
imposed by this collection of
information is 4,252 hours annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FDA Center
No. of
Focus
Groups per
Study
Subject
No. of
Focus
Groups
Sessions
Conducted
Annually
No. of
Participants
per Group
Hours of
Duration for
Each Group
(Includes
Screening)
Total Hours
May use focus groups when appropriate
1
5
9
1.58
71
Center for Drug Evaluation and
Research
Varies (e.g., direct-to-consumer
Rx drug promotion, physician
labeling of Rx drugs, medication guides, over-the-counter
drug labeling, risk communication)
10
200
9
1.58
2,844
Center for Devices and Radiological Health
Varies (e.g., FDA Seal of Approval, patient labeling, tampons, on-line sales of medical
products, latex gloves)
4
16
9
2.08
300
Center for Food Safety and Applied Nutrition
hsrobinson on PROD1PC70 with NOTICES
Center for Biologics Evaluation
and Research
Varies (e.g., food safety, nutrition,
dietary supplements, and consumer education)
8
40
9
1.58
569
Center for Veterinary Medicine
Varies (e.g., animal nutrition, supplements, labeling of animal
Rx)
5
25
9
2.08
468
VerDate Aug<31>2005
14:15 Feb 24, 2006
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Fmt 4703
Sfmt 4703
E:\FR\FM\27FEN1.SGM
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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
]]>Agencies
[Federal Register Volume 71, Number 38 (Monday, February 27, 2006)]
[Notices]
[Pages 9828-9829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0443]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups as Used
by the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
29, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Focus Groups as Used by the Food and Drug Administration--(OMB Control
Number 0910-0497)--Extension
FDA will collect and use information gathered through the focus
group vehicle. This information will be used to develop programmatic
proposals, and as such, compliments other important research findings
to develop these proposals. Focus groups do provide an important role
in gathering information because they allow for a more in-depth
understanding of consumers' attitudes, beliefs, motivations, and
feelings than do quantitative studies.
Also, information from these focus groups will be used to develop
policy and redirect resources, when necessary, to our constituents. If
this information is not collected, a vital link in information
gathering by FDA to develop policy and programmatic proposals will be
missed causing further delays in policy and program development.
In the Federal Register of November 25, 2005 (FR 70 71165), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received one comment, however it was not
related to the information collection.
Annually, FDA projects about 28 focus group studies using 286 focus
groups lasting an average of 1.78 hours each. FDA has allowed burden
for unplanned focus groups to be completed so as not to restrict the
agency's ability to gather information on public sentiment for its
proposals in its regulatory as well as other programs. To arrive at
each center's estimated burden we multiplied the number of focus groups
per study by the number of participants per group. (e.g., Center for
Biologics Evaluation and Research (CBER): 5x9=45). We multiplied that
total by the hours of duration for each group to arrive at the total
burden hours. (e.g., CBER: 45x1.58=71.1).
The total annual estimated burden imposed by this collection of
information is 4,252 hours annually.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Hours of
No. of Focus Duration
Focus Groups No. of for Each
FDA Center Subject Groups per Sessions Participants Group Total Hours
Study Conducted per Group (Includes
Annually Screening)
----------------------------------------------------------------------------------------------------------------
Center for Biologics May use focus groups 1 5 9 1.58 71
Evaluation and when appropriate
Research
----------------------------------------------------------------------------------------------------------------
Center for Drug Varies (e.g., direct- 10 200 9 1.58 2,844
Evaluation and to-consumer Rx drug
Research promotion, physician
labeling of Rx drugs,
medication guides,
over-the-counter drug
labeling, risk
communication)
----------------------------------------------------------------------------------------------------------------
Center for Devices and Varies (e.g., FDA Seal 4 16 9 2.08 300
Radiological Health of Approval, patient
labeling, tampons, on-
line sales of medical
products, latex
gloves)
----------------------------------------------------------------------------------------------------------------
Center for Food Safety Varies (e.g., food 8 40 9 1.58 569
and Applied Nutrition safety, nutrition,
dietary supplements,
and consumer
education)
----------------------------------------------------------------------------------------------------------------
Center for Veterinary Varies (e.g., animal 5 25 9 2.08 468
Medicine nutrition,
supplements, labeling
of animal Rx)
----------------------------------------------------------------------------------------------------------------
[[Page 9829]]
Total ...................... 28 286 ............ 1.78 4,252
----------------------------------------------------------------------------------------------------------------
\1\There 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]
BILLING CODE 4160-01-S
