Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 76654-76655 [E8-29898]
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Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
shares up to 9.9 percent of the voting
shares of Chinatrust Financial Holding
Company, Ltd., Taipei, Taiwan, and
thereby acquire Chinatrust Bank
(U.S.A.), Torrance, California.
Board of Governors of the Federal Reserve
System, December 12, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–29913 Filed 12–16–08; 8:45 am]
Board of Governors of the Federal Reserve
System, December 12, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–29914 Filed 12–16–08; 8:45 am]
BILLING CODE 6210–01–S
BILLING CODE 6210–01–S
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0439]
FEDERAL RESERVE SYSTEM
pwalker on PROD1PC71 with NOTICES
Notice of Proposals to Engage in
Permissible Nonbanking Activities or
to Acquire Companies that are
Engaged in Permissible Nonbanking
Activities
The companies listed in this notice
have given notice under section 4 of the
Bank Holding Company Act (12 U.S.C.
1843) (BHC Act) and Regulation Y (12
CFR Part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
determined by Order to be closely
related to banking and permissible for
bank holding companies. Unless
otherwise noted, these activities will be
conducted throughout the United States.
Each notice is available for inspection
at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act. Additional information on all
bank holding companies may be
obtained from the National Information
Center website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors
not later than January 12, 2008.
A. Federal Reserve Bank of
Richmond (A. Linwood Gill, III, Vice
President) 701 East Byrd Street,
Richmond, Virginia 23261-4528:
1. Capital One Financial Corporation,
McLean, Virginia; to acquire Chevy
Chase Bank, Federal Savings Bank,
McLean, Virginia, and thereby engage in
operation a savings and loan association
pursuant to section 225.28(b)(4)(ii) of
Regulation Y.
VerDate Aug<31>2005
18:58 Dec 16, 2008
Jkt 217001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 January 16,
2009.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0052. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Blood Establishment Registration and
Product Listing, Form FDA 2830—
(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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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,
and must 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), in brief, requires
owners or operators of certain
establishments that engage in the
manufacture of blood products to
register and to submit a list of every
blood product in commercial
distribution. Section 607.21, in brief,
requires the owners or operators of
establishments entering into the
manufacturing of blood products to
register within 5 days after beginning
such operation and to submit a list of
every blood product in commercial
distribution at the time. If the owner or
operator of the establishment has not
previously entered into such operation
for which a license is required,
registration must follow within 5 days
after the submission of a biologics
license application. 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, in brief,
requires certain changes to be submitted
on FDA Form 2830 as amendments to
the establishment registration within 5
days of such changes. Section 607.30(a),
in brief, indicates the information
required for owners or operators of
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, in brief, requires certain foreign
blood product establishments to register
and submit the blood product listing
information, and to provide the name
and address of the establishment and
the name of the individual responsible
for submitting blood product listing
E:\FR\FM\17DEN1.SGM
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76655
Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
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
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 FDA’s Center
for Biologics Evaluation and Research’s
database and FDA experience with the
blood establishment registration and
product listing requirements. The time
needed for industry to complete the
Form FDA 2830 is estimated to be 1
hour for new firms. The blood
establishments for the most part are
familiar with the regulations and
registration requirements to fill out this
form for the first time. Approximately
111 new Form FDA 2830s are received
annually. With annual re-registration of
blood establishments, the time needed
for industry to complete the Form FDA
2830 is estimated to be 0.5 hours. The
blood establishments need only to refer
to their files or written instructions for
a small portion of the information
required. Approximately 2,621 Form
FDA 2830s are received annually for reregistration. Approximately 180 Form
FDA 2830s are received annually for the
product listing update with an
estimated average of 0.25 hours to
complete the form.
In the Federal Register of August 12,
2008 (73 FR 46909), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Form FDA 2830
607.20(a), 607.21,
607.22, 607.25, and
607.40
Initial Registration
607.21, 607.22, 607.25,
607.26, 607.31, and
607.40
Re-registration
607.21, 607.25,
607.30(a), 607.31, and
607.40
No. of
Respondents
Product Listing Update
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
111
1
111
1
111
2,621
1
2,621
0.5
1,311
180
1
180
0.25
45
Total
1,467
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29898 Filed 12–16–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0606]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Food and
Drug Administration Regulated
Products: Export Certificates
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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
VerDate Aug<31>2005
18:58 Dec 16, 2008
Jkt 217001
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
information collection requirements
imposed on firms that intend to export
to countries that require an export
certificate as a condition of entry for
FDA regulated products,
pharmaceuticals, biologics, and devices
as indicated in the Federal Food, Drug,
and Cosmetic Act (the act) as amended.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76654-76655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29898]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0439]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 January
16, 2009.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0052.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Blood Establishment Registration and Product Listing, Form FDA 2830--
(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, and must 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), in brief, requires owners or operators of
certain establishments that engage in the manufacture of blood products
to register and to submit a list of every blood product in commercial
distribution. Section 607.21, in brief, requires the owners or
operators of establishments entering into the manufacturing of blood
products to register within 5 days after beginning such operation and
to submit a list of every blood product in commercial distribution at
the time. If the owner or operator of the establishment has not
previously entered into such operation for which a license is required,
registration must follow within 5 days after the submission of a
biologics license application. 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, in brief, requires certain changes to
be submitted on FDA Form 2830 as amendments to the establishment
registration within 5 days of such changes. Section 607.30(a), in
brief, indicates the information required for owners or operators of
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, in brief, requires certain foreign blood product establishments
to register and submit the blood product listing information, and to
provide the name and address of the establishment and the name of the
individual responsible for submitting blood product listing
[[Page 76655]]
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 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 FDA's Center for Biologics Evaluation
and Research's database and FDA experience with the blood establishment
registration and product listing requirements. The time needed for
industry to complete the Form FDA 2830 is estimated to be 1 hour for
new firms. The blood establishments for the most part are familiar with
the regulations and registration requirements to fill out this form for
the first time. Approximately 111 new Form FDA 2830s are received
annually. With annual re-registration of blood establishments, the time
needed for industry to complete the Form FDA 2830 is estimated to be
0.5 hours. The blood establishments need only to refer to their files
or written instructions for a small portion of the information
required. Approximately 2,621 Form FDA 2830s are received annually for
re-registration. Approximately 180 Form FDA 2830s are received annually
for the product listing update with an estimated average of 0.25 hours
to complete the form.
In the Federal Register of August 12, 2008 (73 FR 46909), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Form FDA No. of Annual Frequency Total Annual Hours per
21 CFR Section 2830 Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
607.20(a), Initial 111 1 111 1 111
607.21, Registratio
607.22, n
607.25, and
607.40
----------------------------------------------------------------------------------------------------------------
607.21, Re- 2,621 1 2,621 0.5 1,311
607.22, registratio
607.25, n
607.26,
607.31, and
607.40
----------------------------------------------------------------------------------------------------------------
607.21, Product 180 1 180 0.25 45
607.25, Listing
607.30(a), Update
607.31, and
607.40
----------------------------------------------------------------------------------------------------------------
Total 1,467
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29898 Filed 12-16-08; 8:45 am]
BILLING CODE 4160-01-S
