Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 61013-61015 [2017-27757]
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27786 Filed 12–22–17; 8:45 am]
BILLING CODE 4164–01–P
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, Form FDA 2830
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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.
SUMMARY:
Submit electronic or written
comments on the collection of
information by February 26, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1069 for ‘‘Blood Establishment
Registration and Product Listing, Form
FDA 2830.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
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, places of
business, and all such establishments,
among other information, and must
submit a list of all drug and all device
products manufactured, prepared,
propagated, compounded, or processed
by him or her for commercial
distribution, among other information.
In 21 CFR part 607, FDA has issued
regulations implementing these
requirements for manufacturers of
human blood and blood products.
Section 607.20(a), requires, in part,
that owners or operators of certain
establishments that engage in the
manufacture of blood products register
and submit a list of every blood product
in commercial distribution.
Section 607.21 requires the owner or
operator of an establishments entering
into the manufacturing of blood
products to register the establishment
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
October 1 and December 31 and update
their blood product listing every June
and December.
Section 607.22(a) requires, in part,
that initial and subsequent registrations
and product listings be submitted
electronically through the Blood
Establishment Registration and Product
Listing system or any future superseding
electronic system.
Section 607.22(b) requires, in part,
that requests for a waiver of the
requirements of § 607.22 be submitted
in writing and include the specific
reasons why electronic submission is
not reasonable for the registrant.
Section 607.22(c) provides that if FDA
grants the waiver request, FDA may
limit its duration and will specify the
terms of the waiver and provide
information on how to submit
establishment registration, drug listings,
other information, and updates, as
applicable (e.g., Form FDA 2830).
Section 607.25 sets forth the
information required for establishment
registration and blood product listing.
Section 607.26 requires, in part, that
certain changes, such as ownership or
location changes, be submitted to FDA
electronically as an amendment to
establishment registration within 5
calendar days of such changes using the
FDA Blood Establishment Registration
and Product Listing system, or any
future superseding electronic system.
Section 607.30(a), in part, sets forth
the information required from owners or
operators of establishments when they
update their blood product listing
information in June and December of
each year (at a minimum).
Section 607.31 requires that certain
additional blood product listing
information be provided upon request
by FDA.
Section 607.40 requires, in part, that
certain foreign blood product
establishments comply with the
establishment registration and blood
product listing information
requirements in part 607, subpart B
(§§ 607.20 through 607.39, 607.40(a) and
(b)), and provide the name and address
of the establishment and the name of the
individual responsible for submitting
establishment registration and blood
product listing information (§ 607.40(c))
as well as the name, address, and phone
number of its U.S. agent (§ 607.40(d)).
This information assists FDA in its
inspections of facilities, among other
uses, and its collection is essential to
the overall regulatory scheme designed
to ensure the safety of the Nation’s
blood supply.
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 the database
of FDA’s Center for Biologics Evaluation
and Research 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
responses per
respondent
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.
607.22(b) ......................................................
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Activity/Form
FDA 2830
Initial Registration .....
115
1
115
1 ......................................
115
Annual Registration ..
2,612
1
2,612
0.5 (30 minutes) .............
1,306
Product Listing Update.
Waiver Requests ......
200
1
200
0.25 (15 minutes) ...........
50
25
........................
25
1 ......................................
25
Total .......................................................
...................................
........................
........................
........................
.........................................
1,496
1 There
Number of
respondents
Average
burden
per response
21 CFR Section
Total annual
responses
are no capital costs of operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
The burden for this information
collection has changed since the last
OMB approval. Because of a slight
increase in the number of initial
registrations and product listing updates
FDA has received during the past 3
years, we have increased our reporting
burden estimate.
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
work days within the parameters
established for one or more other classes
of employees included in the Special
Exposure Cohort.’’
Period of Employment: January 1,
1971 through December 31, 1989.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Frank Hearl
Chief of Staff, National Institute for
Occupational Safety and Health.
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for PubMed
Central National Advisory Committee
(PubMed) was renewed for an
additional two-year period on December
8, 2017.
It is determined that the PubMed is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Claire
Harris, Acting Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.
[FR Doc. 2017–27724 Filed 12–22–17; 8:45 am]
BILLING CODE 4163–19–P
[FR Doc. 2017–27757 Filed 12–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Decision To Evaluate a Petition To
Designate a Class of Employees From
the Ames Laboratory in Ames, Iowa,
To Be Included in the Special
Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
Ames Laboratory in Ames, Iowa, to be
included in the Special Exposure Cohort
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
Authority: 42 CFR 83.9–83.12.
Pursuant to 42 CFR 83.12, the initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Ames Laboratory.
Location: Ames, Iowa.
Job Titles and/or Job Duties: ‘‘All
employees of the Department of Energy,
its predecessor agencies, and their
contractors and subcontractors who
worked in any area at the Ames
Laboratory in Ames, Iowa, during the
period from January 1, 1971 through
December 31, 1989, for a number of
work days aggregating at least 250 work
days, occurring either solely under this
employment or in combination with
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SUMMARY:
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National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel;
Developmental Programming and Aging.
Date: January 17, 2018.
Time: 11:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Ave., Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Greg Bissonette, Ph.D.,
Scientific Review Officer, National Institute
on Aging, National Institutes of Health,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892,
301–402–1622, bissonettegb@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 18, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–27643 Filed 12–22–17; 8:45 am]
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National Institutes of Health
Office of the Director; Notice of Charter
Renewal
Dated: December 20, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–27792 Filed 12–22–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Inherited
Disease Research Access Committee.
Date: January 12, 2018.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61013-61015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27757]
-----------------------------------------------------------------------
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,
Form FDA 2830
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 electronic or written comments on the collection of
information by February 26, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1069 for ``Blood Establishment Registration and Product
Listing, Form FDA 2830.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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
[[Page 61014]]
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, places of
business, and all such establishments, among other information, and
must submit a list of all drug and all device products manufactured,
prepared, propagated, compounded, or processed by him or her for
commercial distribution, among other information. In 21 CFR part 607,
FDA has issued regulations implementing these requirements for
manufacturers of human blood and blood products.
Section 607.20(a), requires, in part, that owners or operators of
certain establishments that engage in the manufacture of blood products
register and submit a list of every blood product in commercial
distribution.
Section 607.21 requires the owner or operator of an establishments
entering into the manufacturing of blood products to register the
establishment 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 October 1 and
December 31 and update their blood product listing every June and
December.
Section 607.22(a) requires, in part, that initial and subsequent
registrations and product listings be submitted electronically through
the Blood Establishment Registration and Product Listing system or any
future superseding electronic system.
Section 607.22(b) requires, in part, that requests for a waiver of
the requirements of Sec. 607.22 be submitted in writing and include
the specific reasons why electronic submission is not reasonable for
the registrant.
Section 607.22(c) provides that if FDA grants the waiver request,
FDA may limit its duration and will specify the terms of the waiver and
provide information on how to submit establishment registration, drug
listings, other information, and updates, as applicable (e.g., Form FDA
2830).
Section 607.25 sets forth the information required for
establishment registration and blood product listing.
Section 607.26 requires, in part, that certain changes, such as
ownership or location changes, be submitted to FDA electronically as an
amendment to establishment registration within 5 calendar days of such
changes using the FDA Blood Establishment Registration and Product
Listing system, or any future superseding electronic system.
Section 607.30(a), in part, sets forth the information required
from owners or operators of establishments when they update their blood
product listing information in June and December of each year (at a
minimum).
Section 607.31 requires that certain additional blood product
listing information be provided upon request by FDA.
Section 607.40 requires, in part, that certain foreign blood
product establishments comply with the establishment registration and
blood product listing information requirements in part 607, subpart B
(Sec. Sec. 607.20 through 607.39, 607.40(a) and (b)), and provide the
name and address of the establishment and the name of the individual
responsible for submitting establishment registration and blood product
listing information (Sec. 607.40(c)) as well as the name, address, and
phone number of its U.S. agent (Sec. 607.40(d)).
This information assists FDA in its inspections of facilities,
among other uses, and its collection is essential to the overall
regulatory scheme designed to ensure the safety of the Nation's blood
supply.
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 the database of FDA's Center for
Biologics Evaluation and Research 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\
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Number of
21 CFR Section Activity/Form FDA Number of responses per Total annual Average burden per response Total hours
2830 respondents respondent responses
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607.20(a), 607.21, 607.22, Initial Registration 115 1 115 1.............................. 115
607.25, and 607.40.
607.21, 607.22, 607.25, 607.26, Annual Registration. 2,612 1 2,612 0.5 (30 minutes)............... 1,306
607.31, and 607.40.
607.21, 607.25, 607.30(a), Product Listing 200 1 200 0.25 (15 minutes).............. 50
607.31, and 607.40. Update.
607.22(b)........................ Waiver Requests..... 25 .............. 25 1.............................. 25
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Total........................ .................... .............. .............. .............. ............................... 1,496
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\1\ There are no capital costs of operating and maintenance costs associated with this collection of information.
[[Page 61015]]
The burden for this information collection has changed since the
last OMB approval. Because of a slight increase in the number of
initial registrations and product listing updates FDA has received
during the past 3 years, we have increased our reporting burden
estimate.
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27757 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P
