Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products, 35118-35119 [2019-15488]
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Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
request to review the documents to
ensure that the contractor has complied
with all regulatory requirements.
C. Annual Reporting Burden
Respondents: 8,256.
Total Annual Responses: 8,256.
Total Burden Hours: 4,128.
D. Public Comment
A 60 day notice was published in the
Federal Register at 84 FR 13921, on
April 9, 2019. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the General
Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F
Street NW, Washington, DC 20405
telephone 202–501–4755. Please cite
OMB Control No. 9000–0053, Permits,
Authorities, or Franchises, in all
correspondence.
Dated: July 16, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–15451 Filed 7–19–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
Total Burden Hours: 75,000.
Affected Public: Business or other forprofit entities.
Respondent’s Obligation: Voluntary.
Type of Request: Extension of a
currently approved collection.
Reporting Frequency: On occasion.
SUPPLEMENTARY INFORMATION:
D. Public Comment
A 60 day notice was published in the
Federal Register at 84 FR 10828 on
March 22, 2019. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the General
Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F
Street NW, Washington, DC 20405,
telephone 202–501–4755. Please cite
OMB Control No. 9000–0082, Economic
Purchase Quantity—Supplies, in all
correspondence.
Dated: July 16, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–15452 Filed 7–19–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0873]
[OMB Control No. 9000–0082; Docket No.
2019–0003; Sequence No. 2]
A. OMB Number, Title, and Any
Associated Form(s)
Submission for OMB Review;
Economic Purchase Quantity—
Supplies
9000–0082, Economic Purchase
Quantity—Supplies.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Bar Code Label
Requirement for Human Drug and
Biological Products
B. Needs and Uses
AGENCY:
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice.
AGENCY:
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve a revision and extension of
a previously approved information
collection requirement concerning
economic purchase quantity—supplies.
DATES: Submit comments on or before
August 21, 2019.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
Additionally submit a copy to GSA by
any of the following methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments. Go to https://
www.regulations.gov and follow the
instructions on the site.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 9000–0082, Economic
Purchase Quantity—Supplies.
Instructions: All items submitted
must cite Information Collection 9000–
0082, Economic Purchase Quantity—
Supplies. Comments received generally
will be posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two-to-three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr.
Michael O. Jackson, Procurement
Analyst, Office of Governmentwide
Acquisition Policy, GSA, 202–208–
4949, or email at michaelo.jackson@
gsa.gov.
VerDate Sep<11>2014
19:11 Jul 19, 2019
Jkt 247001
The provision at 52.207–4, Economic
Purchase Quantity—Supplies, invites
offerors to state an opinion on whether
the quantity of supplies on which bids,
proposals, or quotes are requested in
solicitations is economically
advantageous to the Government. Each
offeror who believes that acquisitions in
different quantities would be more
advantageous is invited to (1)
recommend an economic purchase
quantity, showing a recommended unit
and total price, and (2) identify the
different quantity points where
significant price breaks occur. This
information is required by Public Law
98–577 and Public Law 98–525.
C. Annual Reporting Burden
PO 00000
Respondents: 3,000.
Total Annual Responses: 75,000.
Frm 00051
Fmt 4703
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 21,
2019.
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
SUMMARY:
E:\FR\FM\22JYN1.SGM
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35119
Federal Register / Vol. 84, No. 140 / Monday, July 22, 2019 / Notices
comments should be identified with the
OMB control number 0910–0537. 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.
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:
Bar Code Label Requirement for
Human Drug and Biological Products
OMB Control Number 0910–0537—
Extension
In the Federal Register of February
26, 2004 (69 FR 9120), FDA issued a
final rule that requires human drug
product and biological product labels to
have bar codes. Specifically, the final
rule requires bar codes on most human
prescription drug products and on overthe-counter (OTC) drug products that
are dispensed under an order and
commonly used in healthcare facilities.
It also requires machine-readable
information on blood and blood
components. For human prescription
drug products and OTC drug products
that are dispensed under an order and
commonly used in healthcare facilities,
the bar code must contain the national
drug code number for the product. For
blood and blood components, the final
rule specifies the minimum contents of
the label in a format that is machine
readable and approved for use by the
Director, Center for Biologics Evaluation
and Research. We believe that the final
rule helps reduce the number of
medication errors in hospitals and other
healthcare settings by allowing
healthcare professionals to use bar code
scanning equipment to verify that the
right drug (in the right dose and right
route of administration) is being given
to the right patient at the right time.
Although most of the information
collections created by the final rule have
now been incorporated in OMB
approved information collections
supporting the applicable regulations,
respondents to the collection may
continue to seek an exemption from the
bar code label requirement under
§ 201.25(d) (21 CFR 201.25(d)). Section
201.25(d) requires submission of a
written request for an exemption and
describes the information that must be
included in such a request. Based on the
number of exemption requests we have
received previously, we estimate that
approximately two exemption requests
will be submitted annually and each
exemption request will require 24 hours
to complete. This results in an annual
reporting burden of 48 hours, as
reflected in table 1.
In the Federal Register of November
1, 2018 (83 FR 54930), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate 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
21 CFR 201.25(d) ................................................................
2
1
2
24
48
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Fax written comments on the
collection of information by August 21,
2019.
DATES:
[FR Doc. 2019–15488 Filed 7–19–19; 8:45 am]
BILLING CODE 4164–01–P
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 0910–0813. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1265]
jbell on DSK3GLQ082PROD with NOTICES
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.
SUMMARY:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling:
Nutrition Facts Label and Supplement
Facts Label
FOR FURTHER INFORMATION CONTACT:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
19:11 Jul 19, 2019
Jkt 247001
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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:
Food Labeling: The Nutrition Facts
Label and Supplement Facts Label—21
CFR 101.9
OMB Control Number 0910–0813—
Extension
This information collection supports
requirements for the Nutrition Facts and
Supplemental Facts labels. Section
403(q) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
343(q)) specifies certain nutrients to be
declared in nutrition labeling and
authorizes the Secretary of Health and
Human Services (Secretary) to require
other nutrients to be declared if the
Secretary determines that a nutrient will
provide information regarding the
nutritional value of such food that will
assist consumers in maintaining healthy
dietary practices. The Secretary also has
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]]>Agencies
[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Notices]
[Pages 35118-35119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15488]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0873]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Bar Code Label
Requirement for Human Drug and Biological Products
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 August
21, 2019.
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
[[Page 35119]]
comments should be identified with the OMB control number 0910-0537.
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,
[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.
Bar Code Label Requirement for Human Drug and Biological Products
OMB Control Number 0910-0537--Extension
In the Federal Register of February 26, 2004 (69 FR 9120), FDA
issued a final rule that requires human drug product and biological
product labels to have bar codes. Specifically, the final rule requires
bar codes on most human prescription drug products and on over-the-
counter (OTC) drug products that are dispensed under an order and
commonly used in healthcare facilities. It also requires machine-
readable information on blood and blood components. For human
prescription drug products and OTC drug products that are dispensed
under an order and commonly used in healthcare facilities, the bar code
must contain the national drug code number for the product. For blood
and blood components, the final rule specifies the minimum contents of
the label in a format that is machine readable and approved for use by
the Director, Center for Biologics Evaluation and Research. We believe
that the final rule helps reduce the number of medication errors in
hospitals and other healthcare settings by allowing healthcare
professionals to use bar code scanning equipment to verify that the
right drug (in the right dose and right route of administration) is
being given to the right patient at the right time.
Although most of the information collections created by the final
rule have now been incorporated in OMB approved information collections
supporting the applicable regulations, respondents to the collection
may continue to seek an exemption from the bar code label requirement
under Sec. 201.25(d) (21 CFR 201.25(d)). Section 201.25(d) requires
submission of a written request for an exemption and describes the
information that must be included in such a request. Based on the
number of exemption requests we have received previously, we estimate
that approximately two exemption requests will be submitted annually
and each exemption request will require 24 hours to complete. This
results in an annual reporting burden of 48 hours, as reflected in
table 1.
In the Federal Register of November 1, 2018 (83 FR 54930), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 201.25(d)................................................... 2 1 2 24 48
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15488 Filed 7-19-19; 8:45 am]
BILLING CODE 4164-01-P
