Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Food and Drug Administration Form 2830, 79691-79692 [2011-32777]
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79691
Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices
Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
collection of information to OMB for
review and clearance.
[FR Doc. 2011–32776 Filed 12–21–11; 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; Submission for Office of
Management and Budget Review;
Comment Request; Blood
Establishment Registration and
Product Listing, Food and Drug
Administration Form 2830
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 23,
2012.
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) 395–7285, or emailed 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.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
Blood Establishment Registration and
Product Listing, FDA Form 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
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 FDA
Form 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 FDA Form 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 earlier in this
document 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. FDA Form 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.
In the Federal Register of August 8,
2011 (76 FR 48167), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
jlentini on DSK4TPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
49
1
49
1
49
2,589
1
2,589
0.5
(30 min.)
1,295
Number of
respondents
21 CFR Section
FDA Form 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.
Initial registration ........................
Re-registration ............................
VerDate Mar<15>2010
19:17 Dec 21, 2011
Jkt 226001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\22DEN1.SGM
22DEN1
Total
hours
79692
Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR Section
607.21, 607.25, 607.30(a),
607.31, and 607.40.
Total
hours
180
0.25
(15 min.)
45
.....................................................
........................
........................
....................
....................
1,389
are no capital costs or operating and maintenance costs associated with this collection of information.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
Current Good Manufacturing Practices
and Related Regulations for Blood and
Blood Components; and Requirements
for Donor Testing, Donor Notification,
and ‘‘Lookback’’—(OMB Control
Number 0910–0116)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0511]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practices and Related
Regulations for Blood and Blood
Components; and Requirements for
Donor Testing, Donor Notification, and
‘‘Lookback’’
Food and Drug Administration,
HHS.
Notice.
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 23,
2012.
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) 395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0116. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
jlentini on DSK4TPTVN1PROD with NOTICES
Average
burden per
response
1
[FR Doc. 2011–32777 Filed 12–21–11; 8:45 am]
ACTION:
Total annual
responses
180
Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
Product listing update .................
Total .....................................
1 There
Number of
respondents
FDA Form 2830
Ila
S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
7726, Ila.Mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
19:17 Dec 21, 2011
Jkt 226001
All blood and blood components
introduced or delivered for introduction
into interstate commerce are subject to
section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C. 262).
Section 351(a) of the PHS Act requires
that manufacturers of biological
products, which include blood and
blood components intended for further
manufacture into injectable products,
have a license, issued upon a
demonstration that the product is safe,
pure, and potent and that the
manufacturing establishment meets all
applicable standards, including those
prescribed in the FDA regulations
designed to ensure the continued safety,
purity, and potency of the product. In
addition, under section 361 of the PHS
Act (42 U.S.C. 264), by delegation from
the Secretary of Health and Human
Services, FDA may make and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession.
Section 351(j) of the PHS Act states
that the Federal Food, Drug, and
Cosmetic Act also applies to biological
products. Blood and blood components
for transfusion or for further
manufacture into injectable products are
drugs, as that term is defined in section
201(g)(1) of the Federal, Food, Drug, and
Cosmetics Act (21 U.S.C. 321(g)(1)).
Because blood and blood components
are drugs under the Federal, Food, Drug,
and Cosmetics Act, blood and plasma
establishments must comply with the
substantive provisions and related
regulatory scheme of the act. For
example, under section 501 of the
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Federal, Food, Drug, and Cosmetic Act
(21 U.S.C. 351(a)), drugs are deemed
‘‘adulterated’’ if the methods used in
their manufacturing, processing,
packing, or holding do not conform to
current good manufacturing practice
(CGMP) and related regulations.
The CGMP regulations in part 606 (21
CFR part 606)) and related regulations
implement FDA’s statutory authority to
ensure the safety, purity, and potency of
blood and blood components. The
public health objective in testing human
blood donors for evidence of infection
due to communicable disease agents
and in notifying donors is to prevent the
transmission of communicable disease.
For example, the ‘‘lookback’’
requirements are intended to help
ensure the continued safety of the blood
supply by providing necessary
information to users of blood and blood
components and appropriate
notification of recipients of transfusion
who are at increased risk for
transmitting human immunodeficiency
virus (HIV) or hepatitis C virus (HCV)
infection.
The information collection
requirements in the CGMP, donor
testing, donor notification, and
‘‘lookback’’ regulations provide FDA
with the necessary information to
perform its duty to ensure the safety,
purity, and potency of blood and blood
components. These requirements
establish accountability and traceability
in the processing and handling of blood
and blood components and enable FDA
to perform meaningful inspections.
The recordkeeping requirements serve
preventive and remedial purposes. The
disclosure requirements identify the
various blood and blood components
and important properties of the product,
demonstrate that the CGMP
requirements have been met, and
facilitate the tracing of a product back
to its original source. The reporting
requirements inform FDA of certain
information that may require immediate
corrective action.
Under the reporting requirements,
§ 606.170(b), in brief, requires that
facilities notify FDA’s Center for
Biologics Evaluation and Research
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79691-79692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32777]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0508]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Blood Establishment
Registration and Product Listing, Food and Drug Administration Form
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
23, 2012.
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) 395-7285, or emailed 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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, (301) 796-7726, Ila.Mizrachi@fda.hhs.gov.
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, FDA Form 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
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 FDA Form
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 FDA Form
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 earlier in this document 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. FDA Form 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.
In the Federal Register of August 8, 2011 (76 FR 48167), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR Section FDA Form 2830 Number of responses per annual burden per Total
respondents respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25, and 607.40.. Initial registration.............. 49 1 49 1 49
607.21, 607.22, 607.25, 607.26, 607.31, and Re-registration................... 2,589 1 2,589 0.5 1,295
607.40. (30 min.)
[[Page 79692]]
607.21, 607.25, 607.30(a), 607.31, and 607.40.. Product listing update............ 180 1 180 0.25 45
(15 min.)
--------------------------------------------------------------------
Total...................................... .................................. .............. .............. ........... ........... 1,389
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32777 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P
