Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products, 46940-46941 [2016-17044]
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46940
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
generated for submission to the
regulatory authorities.
Since the E2C(R2) draft guidance was
made available in 2012, ICH has
identified questions linked to the
interpretation and application of the
E2C(R2) guidance. The E2C(R2) Q&A
guidance is intended to clarify questions
relating to implementation of the
E2C(R2) guidance.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidances represent the current
thinking of FDA on the E2C(R2) PBRER.
They do not establish any rights for any
person and are not binding on FDA or
the public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
II. The Paperwork Reduction Act of
1995
SUMMARY:
These guidances refer to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3520). The collection of
information in the ‘‘Guidance on
Reporting in Accordance with
International Council for
Harmonisation—Periodic Benefit-Risk
Evaluation Report (E2C(R2)) and
Providing Waiver-Related Materials’’
has been approved under OMB control
number 0910–0771. The guidances also
reference other collections of
information. The collection of
information in 21 CFR 314.80 has been
approved under OMB control number
0910–0230, and the collection of
information in 21 CFR 600.80 has been
approved under OMB control number
0910–0308.
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III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
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19:39 Jul 18, 2016
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[FR Doc. 2016–17009 Filed 7–18–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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 18,
2016.
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 0910–0537. 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, Three White
Flint North 10A–12M, 11601
Landsdown Street, North Bethesda, MD
20852, 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.
Bar Code Label Requirement for
Human Drug Products and Blood; OMB
Control No. 0910–0537—Extension
In the Federal Register of February
26, 2004 (69 FR 9120), FDA issued a
PO 00000
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final rule that requires human drug
product and biological product labels to
have bar codes. Specifically, the 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 health care facilities.
The rule 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 health care facilities,
the bar code must contain the NDC
number for the product. For blood and
blood components, the 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 the rule helps to reduce the
number of medication errors in
hospitals and other health care settings
by allowing health care 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.
While most of the information
collection burdens created by the final
rule have now been incorporated into
currently 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 2 exemption requests
will be submitted annually and that
each exemption request will require 24
hours to complete. This results in an
annual reporting burden of 48 hours, as
reflected below in Table 1.
In the Federal Register of December
15, 2015 (80 FR 77637) FDA 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:
E:\FR\FM\19JYN1.SGM
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46941
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
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
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.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Participation’’ heading, the first
sentence is corrected to read
‘‘Registration information, the agenda,
and additional background materials
can be found at https://www.fda.gov/
NewsEvents/
MeetingsConferencesWorkshops/
ucm506658.htm.
[FR Doc. 2016–17044 Filed 7–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
[FR Doc. 2016–17015 Filed 7–18–16; 8:45 am]
Pediatric Clinical Investigator Training
Workshop; Correction
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; Correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on June 16, 2016 (81 FR 39271).
The document announced a ‘‘Pediatric
Clinical Investigator Training’’
workshop and contained an incorrect
Web link for registration and an
incorrect Web link for more information
on the workshop. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Crescenzi, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
terrie.crescenzi@fda.hhs.gov or Betsy
Sanford, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
elizabeth.sanford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Thursday, June 16,
2016, in FR Doc. 2016–14230, on page
39272, the following corrections are
made:
1. On page 39272, in the first column,
in the first paragraph under the
‘‘Workshop Attendance and
Participation’’ heading, the first
sentence is corrected to read ‘‘If you
wish to attend this workshop, visit
https://www.eventbrite.com/e/pediatricclinical-investigator-training-workshoptickets-19708166657.
2. On page 39272, in the first column,
in the second paragraph under the
‘‘Workshop Attendance and
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request—Scholarships for
Disadvantaged Students Program
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c) (2) (A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than September 19,
2016.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Scholarships for Disadvantaged
Students (SDS) Program.
OMB No. 0915–0149—Revision.
Abstract: The program specific form
for the SDS program has been revised to
reflect a change in the order of the fields
only. Fields K (Public or Non Profit
Institution) and H (Point of Contact)
have been moved to fields A and B
respectively. Now Field A is Public or
Non Profit Institution and Field B is
Point of Contact. All other fields
remained in sequence but were renamed
with the appropriate letter order.
Need and Proposed Use of the
Information: The purpose of the SDS
Program is to provide funds to eligible
schools to provide scholarships to fulltime, financially needy students from
disadvantaged backgrounds enrolled in
health professions programs. To qualify
for participation in the SDS program, a
school must be carrying out a program
for recruiting and retaining students
from disadvantaged backgrounds,
including students who are members of
racial and ethnic minority groups
(section 737(d)(1)(B) of the Public
Health Service (PHS) Act). A school
must meet the eligibility criteria to
demonstrate that the program has
achieved success based on the number
and/or percentage of disadvantaged
students who graduate from the school.
In awarding SDS funds to eligible
schools, funding points must be given to
schools based on the proportion of
graduating students going into primary
care, the proportion of underrepresented
minority students, and the proportion of
graduates working in medically
underserved communities (section
737(c) of the PHS Act).
Likely Respondents: The respondents
are institutions that will be applying to
the SDS program every four years.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
E:\FR\FM\19JYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46940-46941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17044]
-----------------------------------------------------------------------
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
18, 2016.
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 0910-0537.
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, Three White Flint North 10A-12M, 11601
Landsdown Street, North Bethesda, MD 20852, 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.
Bar Code Label Requirement for Human Drug Products and Blood; OMB
Control No. 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 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 health care facilities. The rule 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 health care facilities, the bar code must contain the
NDC number for the product. For blood and blood components, the 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 the rule helps to reduce
the number of medication errors in hospitals and other health care
settings by allowing health care 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.
While most of the information collection burdens created by the
final rule have now been incorporated into currently 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 2 exemption
requests will be submitted annually and that each exemption request
will require 24 hours to complete. This results in an annual reporting
burden of 48 hours, as reflected below in Table 1.
In the Federal Register of December 15, 2015 (80 FR 77637) FDA
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:
[[Page 46941]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17044 Filed 7-18-16; 8:45 am]
BILLING CODE 4164-01-P
