Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, 46838-46839 [2014-18945]
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46838
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1069]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Blood
Establishment Registration and
Product Listing
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 on Form FDA 2830.
DATES: Submit electronic or written
comments on the collection of
information by October 10, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
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
his or her name, place of business, and
all such establishments with the
Secretary of Health and Human Services
on or before December 31 of each year.
He or she must also 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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
update their blood product listing every
June and December.
Section 607.22 requires the use of
Form FDA 2830, Blood Establishment
Registration and Product Listing, for
initial registration, for 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 the 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 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.
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
46839
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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.
Re-registration.
Product Updating List.
Total ....................................................
1 There
......................
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18945 Filed 8–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1081]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic; Availability
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 guidance which discusses FDA’s
approach to enforcement of adverse
event reporting requirements during an
influenza pandemic.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Total annual
responses
68
1
68
2,615
1
2,615
166
1
166
........................
........................
........................
Average
burden per
response
Total hours
1 ....................
68
0.5 (30 minutes).
0.25 (15 minutes).
1,308
.......................
1,418
42
are no capital costs of operating and maintenance costs associated with this collection of information.
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.
AGENCY:
Number of
respondents
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
Submit either electronic or
written comments on the collection of
information by October 10, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
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
(OMB Control Number 0910–0701)—
Extension
DATES:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic; Availability
The guidance includes
recommendations for planning,
notification, and documentation for
firms that report postmarketing adverse
events. The guidance recommends that
each firm’s pandemic influenza
continuity of operations plan (COOP)
include instructions for reporting
adverse events, including a plan for the
submission of stored reports that were
not submitted within regulatory
timeframes. The guidance explains that
firms that are unable to fulfill normal
adverse event reporting requirements
during an influenza pandemic should:
(1) Maintain documentation of the
conditions that prevent them from
meeting normal reporting requirements;
(2) notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist and when the
reporting process is restored; and (3)
maintain records to identify what
reports have been stored.
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46838-46839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18945]
[[Page 46838]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1069]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Blood Establishment Registration and Product Listing
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 on Form
FDA 2830.
DATES: Submit electronic or written comments on the collection of
information by October 10, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 his or her name, place of business, and all such
establishments with the Secretary of Health and Human Services on or
before December 31 of each year. He or she must also 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
update their blood product listing every June and December.
Section 607.22 requires the use of Form FDA 2830, Blood
Establishment Registration and Product Listing, for initial
registration, for 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 the 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 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.
[[Page 46839]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Form FDA 2830 Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25, Initial Registration.... 68 1 68 1...................... 68
and 607.40.
607.21, 607.22, 607.25, 607.26, Re-registration......... 2,615 1 2,615 0.5 (30 minutes)....... 1,308
607.31, and 607.40.
607.21, 607.25, 607.30(a), 607.31, Product Updating List... 166 1 166 0.25 (15 minutes)...... 42
and 607.40.
----------------------------------------------------------------------------------------
Total............................ ........................ .............. .............. .............. ....................... 1,418
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs of operating and maintenance costs associated with this collection of information.
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.
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18945 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P
