Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 49655-49656 [05-16847]
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Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
notify their direct accounts of the recall
and to provide recipients with a ready
means of reporting to the recalling firm.
Under these portions of the collection of
information, the agency estimates it will
receive 2,375 responses annually for
each.
Recall Status Reports
Requests that recalling firms provide
periodic status reports so FDA can
ascertain the progress of the recall. This
collection of information will generate
approximately 9,500 responses
annually.
In the Federal Register of October 12,
2004 (69 FR 60630), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16846 Filed 8–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0327]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Blood
Establishment Registration and
Product Listing, Form FDA 2830
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 information collection requirements
relating to the blood establishment
registration and product listing
requirements and Form FDA 2830.
DATES: Submit written or electronic
comments on the collection of
information by October 24, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments. Submit written
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
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:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
Blood Establishment Registration and
Product Listing, Form FDA 2830—21
CFR Part 607 (OMB Control Number
0910–0052)—Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an
establishment that manufactures,
prepares, propagates, compounds, or
processes a drug or device must register
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
49655
with the Secretary of Health and Human
Services, on or before December 31 of
each year, his or her name, place of
business, and all such establishments
submit, among other information, a
listing of all drug or device products
manufactured, prepared, propagated,
compounded, or processed by him or
her for commercial distribution. In part
607 (21 CFR part 607), FDA has issued
regulations implementing these
requirements for manufacturers of
human blood and blood products.
Section 607.20(a) requires certain
establishments that engage in the
manufacture of blood products to
register and to submit a list of blood
products in commercial distribution.
Section 607.21 requires the
establishments entering into the
manufacturing of blood products to
register within 5 days after beginning
such operation and to submit a blood
product listing at that time. In addition,
establishments are required to register
annually between November 15 and
December 31 and update their blood
product listing every June and
December of each year. Section 607.22
requires the use of Form FDA 2830,
Blood Establishment Registration and
Product Listing, for initial registration,
for annual registration, and for blood
product listing. Section 607.25 indicates
the information required for
establishment registration and blood
product listing. Section 607.26 requires
certain changes to be submitted as
amendments to the establishment
registration within 5 days of such
changes. Section 607.30 requires
establishments to update their blood
product listing information every June
and December, or at the discretion of the
registrant at the time the change occurs.
Section 607.31 requires that additional
blood product listing information be
provided upon FDA request. Section
607.40 requires foreign blood product
establishments to register and submit
the blood product listing information,
the name and address of the
establishment, and the name of the
individual responsible for submitting
blood product listing information as
well as the name, address, and phone
number of its U.S. agent.
Among other uses, this information
assists FDA in its inspections of
facilities, and its collection is essential
to the overall regulatory scheme
designed to ensure the safety of the
Nation’s blood supply. Form FDA 2830
is used to collect this information.
Respondents to this collection of
information are human blood and
plasma donor centers, blood banks,
certain transfusion services, other blood
product manufacturers, and
E:\FR\FM\24AUN1.SGM
24AUN1
49656
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
independent laboratories that engage in
quality control and testing for registered
blood product establishments.
FDA estimates the burden of this
collection of information based upon
information obtained from the Center
for Biologics Evaluation and Research’s
database and FDA experience with the
blood establishment registration and
product listing requirements.
FDA estimates the burden of this
collection as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
1
2,775
180
1
180
Reregistration
607.21, 607.25, 607.30, 607.31, and 607.40
100
Initial registration
607.21, 607.22, 607.25, 607.26, 607.31, and
607.40
1
2,775
607.20(a), 607.21, 607.22, 607.25, and 607.40
Total Annual
Responses
100
Form FDA 2830
Annual
Frequency
per
Response
Product listing update
Hours per
Response
1
0.5
100
1,388
0.25
Total
1
Total
Hours
45
1,533
There are no capital costs of operating and maintenance costs associated with this collection of information.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16847 Filed 8–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on certain device panels of the
Medical Devices Advisory Committee,
the National Mammography Quality
Assurance Advisory Committee, the
Device Good Manufacturing Practice
Advisory Committee, and the Technical
Electronic Products Radiation Safety
Standards Committee in the Center for
Devices and Radiological Health.
Nominations will be accepted for
current vacancies and those that will or
may occur through August 31, 2006.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Because scheduled vacancies
occur on various dates throughout each
year, no cutoff date is established for the
receipt of nominations. However, when
possible, nominations should be
received at least 6 months before the
date of scheduled vacancies for each
year, as indicated in this notice.
ADDRESSES: Send all nominations and
curricula vitae to the following contact
persons in table 1 of this document:
TABLE 1.
Contact Person
Committee/Panel
Nancy J. Pluhowski, Center for Devices and Radiological Health (HFZ–400), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2022, or
e-mail: NJP@CDRH.FDA.GOV
Certain Device Panels of the Medical Devices Advisory Committee
Charles A. Finder, Center for Devices and Radiological Health (HFZ–240), Food and
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail:
CAF@CDRH.FDA.GOV
National Mammography Quality Assurance Advisory
Committee
Collin L. Figueroa, Center for Devices and Radiological Health (HFZ–342), Food and
Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, e-mail:
CXF@CDRH.FDA.GOV
Device Good Manufacturing Practice Advisory Committee
Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ–240), Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail:
RVK@CDRH.FDA.GOV
Technical Electronic Product Radiation Safety
Standards Committee
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 2098 Gaither
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
Rd., Rockville, MD 20850, 240–276–
0450, ext. 114, e-mail:
KLW@CDRH.FDA.GOV.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
I. Vacancies
FDA is requesting nominations of
voting members for vacancies listed as
follows:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49655-49656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0327]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Blood Establishment Registration and Product Listing,
Form FDA 2830
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 information collection
requirements relating to the blood establishment registration and
product listing requirements and Form FDA 2830.
DATES: Submit written or electronic comments on the collection of
information by October 24, 2005.
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: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Blood Establishment Registration and Product Listing, Form FDA 2830--21
CFR Part 607 (OMB Control Number 0910-0052)--Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, place of
business, and all such establishments submit, among other information,
a listing of all drug or device products manufactured, prepared,
propagated, compounded, or processed by him or her for commercial
distribution. In part 607 (21 CFR part 607), FDA has issued regulations
implementing these requirements for manufacturers of human blood and
blood products.
Section 607.20(a) requires certain establishments that engage in
the manufacture of blood products to register and to submit a list of
blood products in commercial distribution. Section 607.21 requires the
establishments entering into the manufacturing of blood products to
register within 5 days after beginning such operation and to submit a
blood product listing at that time. In addition, establishments are
required to register annually between November 15 and December 31 and
update their blood product listing every June and December of each
year. Section 607.22 requires the use of Form FDA 2830, Blood
Establishment Registration and Product Listing, for initial
registration, for annual registration, and for blood product listing.
Section 607.25 indicates the information required for establishment
registration and blood product listing. Section 607.26 requires certain
changes to be submitted as amendments to the establishment registration
within 5 days of such changes. Section 607.30 requires establishments
to update their blood product listing information every June and
December, or at the discretion of the registrant at the time the change
occurs. Section 607.31 requires that additional blood product listing
information be provided upon FDA request. Section 607.40 requires
foreign blood product establishments to register and submit the blood
product listing information, the name and address of the establishment,
and the name of the individual responsible for submitting blood product
listing information as well as the name, address, and phone number of
its U.S. agent.
Among other uses, this information assists FDA in its inspections
of facilities, and its collection is essential to the overall
regulatory scheme designed to ensure the safety of the Nation's blood
supply. Form FDA 2830 is used to collect this information.
Respondents to this collection of information are human blood and
plasma donor centers, blood banks, certain transfusion services, other
blood product manufacturers, and
[[Page 49656]]
independent laboratories that engage in quality control and testing for
registered blood product establishments.
FDA estimates the burden of this collection of information based
upon information obtained from the Center for Biologics Evaluation and
Research's database and FDA experience with the blood establishment
registration and product listing requirements.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency Total Annual Hours per Total
21 CFR Section Form FDA 2830 Respondents per Responses Response Hours
Response
----------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, Initial registration 100 1 100 1 100
607.25, and 607.40
-----------------------------
607.21, 607.22, 607.25, Reregistration 2,775 1 2,775 0.5 1,388
607.26, 607.31, and 607.40
-----------------------------
607.21, 607.25, 607.30, Product listing 180 1 180 0.25 45
607.31, and 607.40 update
-----------------------------
Total 1,533
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs of operating and maintenance costs associated with this collection of
information.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16847 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S
