Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, 4932-4933 [2015-01670]
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4932
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
guidance details information on how the
Agency intends to interpret and apply
provisions of the existing regulations
regarding internal Agency review of
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants or
manufacturers, for animal drugs or other
products regulated by CVM, that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established Agency
channels of supervision for review.
In the Federal Register of November
6, 2014 (79 FR 65976), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but it did not respond to any of the four
collection of information topics
solicited in the notice and therefore is
not discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
10.75 ....................................................................................
2
4
8
10
80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
CVM encourages applicants to begin
the resolution of science-based disputes
with discussions with the review team/
group, including the Team Leader or
Division Director. The Center prefers
that differences of opinion regarding
science or science-based policy be
resolved between the review team/group
and the applicant. If the matter is not
resolved by this preferred method, then
CVM recommends that the applicant
follow the procedure in guidance for
industry #79. Of the two respondents
who were advised on the procedure
during the past 3 years, one has not
followed up to initiate it and the other
is working with the review team/group
to resolve the issue(s). Therefore, this
estimated annual reporting burden is
based on CVM’s previous experience in
handling formal appeals for scientific
disputes.
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01669 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
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 March 2,
2015.
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.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood Establishment Registration and
Product Listing, Form FDA 2830—21
CFR Part 607 (OMB Control Number
0910–0052)—Extension
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1069]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Blood
Establishment Registration and
Product Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
18:16 Jan 28, 2015
Jkt 235001
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.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29JAN1.SGM
29JAN1
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
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.
4933
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.
In the Federal Register of August 11,
2014 (79 FR 46838), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
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.
Total .............................................
Initial Registration
1 There
Average
burden per
response
Total
hours
68
1 ...........................
68
Re-registration ......
2,615
1
2,615
0.5 (30 minutes) ...
1,308
Product Updating
List.
..............................
166
1
166
........................
........................
........................
0.25 (15 minutes)
..............................
42
1,418
are no capital costs of operating and maintenance costs associated with this collection of information
[FR Doc. 2015–01670 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The public workshop will be
held on March 30 and 31, 2015, from
8:30 a.m. to 5 p.m.
Gastroenterology Regulatory
Endpoints and the Advancement of
Therapeutics; Public Workshop
Food and Drug Administration,
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research, in
cosponsorship with the American
College of Gastroenterology, the
American Gastroenterological
Association, the Crohn’s and Colitis
Foundation of America, Inc., the North
VerDate Sep<11>2014
18:16 Jan 28, 2015
Jkt 235001
The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
ADDRESSES:
HHS.
SUMMARY:
American Society for Pediatric
Gastroenterology, Hepatology, and
Nutrition, the North American Society
for the Study of Celiac Disease, and the
Pediatric Inflammatory Bowel Disease
Foundation, is announcing a 2-day
public workshop entitled
‘‘Gastroenterology Regulatory Endpoints
and the Advancement of Therapeutics
(GREAT III).’’ The purpose of this
workshop is to provide a forum to
consider issues related to selection of
endpoints and clinical outcome
measures appropriate for drug
development in the following disease
areas: Inflammatory bowel diseases and
celiac disease.
DATES:
[Docket No. FDA–2015–N–0001]
ACTION:
Total annual
responses
1
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
68
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
respondents
Form FDA 2830
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Kelly Richards, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Rm. 5237, Silver
Spring, MD 20993–0002, 240–402–4276,
FAX: 301–796–9904, email: GREAT@
fda.hhs.gov.
This
workshop will address endpoints for
registration trials in inflammatory bowel
diseases and celiac disease.
Stakeholders, including industry
sponsors, academia, patients and FDA,
will address challenging issues related
to selection of endpoints and
assessment methodologies in clinical
trials intended to support approval of
products for treatment of inflammatory
bowel diseases and celiac disease. The
first day of the workshop will discuss
the assessment of efficacy in Crohn’s
disease trials, including the use of
patient-reported outcome measures and
endoscopic evaluation, as well as the
role of registries and patient
participation in inflammatory bowel
disease drug development programs.
The second day of the workshop will
discuss the appropriate target
population for pharmacological therapy
in celiac disease, and the definition and
measurement of a treatment benefit in
celiac disease registration trials,
including the role and timing of
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29JAN1.SGM
29JAN1
Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4932-4933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1069]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 March
2, 2015.
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: 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: 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--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
[[Page 4933]]
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.
In the Federal Register of August 11, 2014 (79 FR 46838), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
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
respondents respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25, and Initial Registration..... 68 1 68 1........................ 68
607.40.
607.21, 607.22, 607.25, 607.26, 607.31, Re-registration.......... 2,615 1 2,615 0.5 (30 minutes)......... 1,308
and 607.40.
607.21, 607.25, 607.30(a), 607.31, and Product Updating List.... 166 1 166 0.25 (15 minutes)........ 42
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: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01670 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P