Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 15147-15148 [2018-07145]
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
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Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
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requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
The FTC Act and other laws that the
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before May 9, 2018. For information on
the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/
site-information/privacy-policy.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2018–07127 Filed 4–6–18; 8:45 am]
BILLING CODE 6750–01–P
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, Form FDA 2830
sradovich on DSK3GMQ082PROD with NOTICES
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
SUMMARY:
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 9,
2018.
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:
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.
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:
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 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), 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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
15147
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))
E:\FR\FM\09APN1.SGM
09APN1
15148
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
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.
In the Federal Register of December
26, 2017 (82 FR 61013), 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
Activity/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.
607.22(b) .........................................
Initial Registration.
Annual Registration.
Product Listing
Update.
Waiver Requests
Total .........................................
............................
1There
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07145 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0545]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request
AGENCY:
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 May 9,
2018.
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Average burden
per
response
Total annual
responses
Total hours
115
1
115
1 .........................
115
2,612
1
2,612
1,306
200
1
200
25
........................
25
0.5 ......................
(30 minutes) .......
0.25 ....................
(15 minutes) .......
1 .........................
........................
........................
........................
............................
1,496
50
25
are no capital costs of operating and maintenance costs associated with this collection of information.
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.
ACTION:
Number of
respondents
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
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 0910–0256. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
ADDRESSES:
Infant Formula Requirements—21 CFR
parts 106 and 107
OMB Control Number 0910–0256—
Extension
This information collection supports
FDA regulations regarding infant
formula requirements. Statutory
requirements for infant formula under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) are intended to protect
the health of infants and include a
number of reporting and recordkeeping
requirements. Among other things,
section 412 of the FD&C Act (21 U.S.C.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
350a) requires manufacturers of infant
formula to establish and adhere to
quality control procedures, notify us
when a batch of infant formula that has
left the manufacturers’ control may be
adulterated or misbranded, and keep
records of distribution. We also regulate
the labeling of infant formula under the
authority of section 403 of the FD&C Act
(21 U.S.C. 343). The purpose of the
labeling requirements is to ensure that
consumers have the information they
need to prepare and use infant formula
appropriately. The regulations for infant
formula requirements are codified in 21
CFR parts 106 and 107.
To assist respondents with applicable
reporting provisions found in the
regulations, we have developed an
electronic Form FDA 3978 that allows
infant formula manufacturers to
electronically submit reports and
notifications in a standardized format.
Form FDA 3978 prompts respondents to
include information in a standardized
format and helps respondents organize
submissions to include only the
information needed for our review. Draft
screenshots of Form FDA 3978 and
instructions are available at https://
www.fda.gov/Food/
GuidanceRegulation/
FoodFacilityRegistration/
InfantFormula/default.htm. Form FDA
3978 was deployed in 2017 as a pilot by
FDA and, while informal feedback
regarding its use has been favorable, we
continue to invite comment. If
manufacturers prefer, however, FDA
continues to accept paper submissions.
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15147-15148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07145]
=======================================================================
-----------------------------------------------------------------------
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, Form FDA 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 May 9,
2018.
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 [email protected]. 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 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: 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 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 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), 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))
[[Page 15148]]
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.
In the Federal Register of December 26, 2017 (82 FR 61013), 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 Activity/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.... 115 1 115 1...................... 115
and 607.40.
607.21, 607.22, 607.25, 607.26, Annual Registration..... 2,612 1 2,612 0.5.................... 1,306
607.31, and 607.40. (30 minutes)...........
607.21, 607.25, 607.30(a), 607.31, Product Listing Update.. 200 1 200 0.25................... 50
and 607.40. (15 minutes)...........
607.22(b)............................ Waiver Requests......... 25 .............. 25 1...................... 25
------------------------------------------------------------------------------------------------------------------
Total............................ ........................ .............. .............. .............. ....................... 1,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs of operating and maintenance costs associated with this collection of information.
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: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07145 Filed 4-6-18; 8:45 am]
BILLING CODE 4164-01-P
