Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 48167-48168 [2011-19955]
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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
postmarketing clinical trials, additional
product stability studies, complaint
handling, recalls, postmarket reporting
of the dissemination of advertising and
promotional labeling materials as
required under § 601.12(f)(4) and
adverse experience reporting. We
recommend that the final product
manufacturer establish a procedure with
the other participating manufacturer(s)
to obtain information in these areas.
Description of Respondents: The
recordkeeping and reporting
recommendations described in this
document affect the participating
licensed manufacturer(s), final product
manufacturer(s), and contract
manufacturer(s) associated with
cooperative manufacturing
arrangements.
Burden Estimate: We believe that the
information collection provisions in the
guidance do not create a new burden for
respondents. We believe the reporting
and recordkeeping provisions are part of
usual and customary business practices.
Licensed manufacturers would have
contractual agreements with
participating licensed manufacturers,
final product manufacturers, and
contract manufacturers, as applicable
for the type of cooperative
manufacturing arrangement, to address
all these information collection
provisions.
The guidance also refers to previously
approved collections of information
found in FDA regulations at parts 201,
207, 211, 600, 601, 606, 607, 610, 660,
801, 803, and 807, 809, and 820 (21 CFR
parts 201, 207, 211, 600, 601, 606, 607,
610, 660, 801, 803, 807, 809, and 820).
The collections of information in
§§ 606.121, 606.122, and 610.40 have
been approved under OMB control
number 0910–0116; § 610.2 has been
approved under OMB control number
0910–0206; §§ 600.12(e) and 600.80
have been approved under OMB control
number 0910–0308; §§ 601.2(a), 601.12,
610.60 through 610.65, 610.67, 660.2(c),
660.28(a) and (b), 660.35(a), (c) through
(g), and (i) through (m), 660.45, and
660.55(a) and (b) have been approved
under OMB control number 0910–0338;
§§ 803.20, 803.50, and 803.53 have been
approved under OMB control number
0910–0437; and §§ 600.14 and 606.171
have been approved under OMB control
number 0910–0458. The current good
manufacturing practice regulations for
finished pharmaceuticals (part 211)
have been approved under OMB control
number 0910–0139; §§ 820.181 and
820.184 have been approved under
OMB control number 0910–0073; the
establishment registration regulations
(parts 207, 607, and 807) have been
approved under OMB control numbers
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
0910–0045, 0910–0052, and 0910–0387;
and the labeling regulations (parts 201,
801, and 809) have been approved
under OMB control numbers 0910–
0537, 0910–0572, and 0910–0485.
In the Federal Register of March 16,
2011 (76 FR 14405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received from the public.
Dated: August 2, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–19958 Filed 8–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0508]
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.
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 in the Agency’s
regulations and Form FDA 2830.
DATES: Submit either electronic or
written comments on the collection of
information by October 7, 2011.
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
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
48167
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651.
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,
and must submit, among other
E:\FR\FM\08AUN1.SGM
08AUN1
48168
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
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, owners
or operators of all establishments so
engaged must register annually between
November 15 and December 31 and
must update their blood product listing
information every June and December.
Section 607.22 requires the use of Form
FDA 2830 (Blood Establishment
Registration and Product Listing) for
initial registration, subsequent annual
registration, and for blood product
listing information. Section 607.25 sets
forth the information required for
establishment registration and blood
product listing. Section 607.26, in brief,
requires certain changes to be submitted
on Form FDA 2830 as an amendment to
establishment registration within 5 days
of such changes. Section 607.30(a), in
brief, sets forth the information required
from owners or operators of
establishments when updating 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 comply with the
establishment registration and blood
product listing information
requirements discussed above and to
provide the name and address of the
establishment and the name of the
individual responsible for submitting
establishment registration and 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
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses
per respondent
Total annual
responses
Average
burden per
response
(in hours)
21 CFR Section
Form FDA 2830
607.20(a), 607.21, 607.22, 607.25, and
607.40.
607.21, 607.22, 607.25, 607.26, 607.31, and
607.40.
607.21, 607.25, 607.30(a), 607.31, and
607.40.
Initial Registration .......
49
1
49
Re-registration ............
2,589
1
2,589
Product Listing Update
180
1
180
0.25
45
Total .........................................................
.....................................
....................
....................
....................
....................
1,388
1 There
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2011–N–0126]
Andrew K. Choi: Debarment Order
Food and Drug Administration,
HHS.
Notice.
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Andrew K. Choi, M.D. for 4 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on findings that Dr. Choi was
convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
Dr. Choi was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Dr.
Choi failed to respond. Dr. Choi’s failure
SUMMARY:
[FR Doc. 2011–19955 Filed 8–5–11; 8:45 am]
ACTION:
1
0.5
49
1,294
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 26, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
AGENCY:
Total hours
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
to respond constitutes a waiver of his
right to a hearing concerning this action.
DATES:
This order is effective August 8,
2011.
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48167-48168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19955]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0508]
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 in the Agency's regulations and Form FDA
2830.
DATES: Submit either electronic or written comments on the collection
of information by October 7, 2011.
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.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651.
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, and must submit, among other
[[Page 48168]]
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, owners or operators of all
establishments so engaged must register annually between November 15
and December 31 and must update their blood product listing information
every June and December. Section 607.22 requires the use of Form FDA
2830 (Blood Establishment Registration and Product Listing) for initial
registration, subsequent annual registration, and for blood product
listing information. Section 607.25 sets forth the information required
for establishment registration and blood product listing. Section
607.26, in brief, requires certain changes to be submitted on Form FDA
2830 as an amendment to establishment registration within 5 days of
such changes. Section 607.30(a), in brief, sets forth the information
required from owners or operators of establishments when updating 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 comply with the establishment
registration and blood product listing information requirements
discussed above and to provide the name and address of the
establishment and the name of the individual responsible for submitting
establishment registration and 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses Total burden per
21 CFR Section Form FDA 2830 respondents per annual response Total hours
respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, Initial 49 1 49 1 49
607.25, and 607.40. Registration.
607.21, 607.22, 607.25, Re-registration. 2,589 1 2,589 0.5 1,294
607.26, 607.31, and 607.40.
607.21, 607.25, 607.30(a), Product Listing 180 1 180 0.25 45
607.31, and 607.40. Update.
----------------------------------------------------------------
Total.................... ................ ........... ........... ........... ........... 1,388
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 26, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19955 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P
