Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products, 54930-54932 [2018-23910]
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Notices
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Report of Illness or Death: Interstate
Travel of Persons (42 CFR part 70)—
Revision—National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Section 361 of the Public Health
Service Act (42 U.S.C. 264) authorizes
the Secretary of the Department of
Health and Human Services to make
and enforce regulations necessary to
prevent the introduction, transmission,
or spread of communicable diseases
from foreign countries into the United
States, or from one State or possession
into any other State or possession. CDC
administers regulations pertaining to
interstate control of communicable
diseases (42 CFR part 70), and sections
42 CFR parts 70.4 and 70.11 include
requirements for reports of ill persons or
death if occurring during interstate
travel.
The intended use of the information
is to ensure that CDC can assess and
respond to reports of ill persons or
death that occur on conveyances
engaged in interstate travel, and assist
state and local health authorities if an
illness or death occurs that poses a risk
to public health. Generally, the primary
source of this information is aircraft
traveling within the United States.
In 2017, CDC finalized the Control of
Communicable Disease regulations (42
CFR 70 and 71). With this new
provision, CDC divided the total
anticipated reporting burden between
70.11 and 70.4 in the accompanying
Paperwork Reduction Act section of the
rule, assuming that aircraft would report
most cases of ill people and deaths to
CDC, with some airlines and other
conveyances reporting still to local
public health authorities. For reports of
ill persons or death on a conveyance
engaged in interstate traffic, the
requested burden is approximately 23
hours. This total is estimated from 200
respondents submitting domestic
reports of death or communicable
disease a year, with an average burden
of 7 minutes per report. The only
requested change to the approved data
collection is a change in title from
‘‘Restriction on Travel of Persons (42
CFR part 70)’’ to ‘‘Report of Illness or
Death: Interstate Travel of Persons (42
CFR part 70)’’. This results in two rows
in the burden table, but with no
additional burden. The estimated
annual Burden Hours are 23. There is no
cost to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Pilot in command ....................
42 CFR 70.11 Report of death or illness onboard aircraft
operated by airline.
42 CFR 70.4 Report by the master of a vessel or person
in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel.
Master of vessel or person in
charge of conveyance.
Jeffrey M. Zirger
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–23861 Filed 10–31–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2012–N–0873]
Agency Information Collection
Activities; Proposed Collection;
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 or Agency) is
SUMMARY:
VerDate Sep<11>2014
20:30 Oct 31, 2018
Jkt 247001
Number of
respondents
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 bar code label
requirements for human drug and
biological products.
DATES: Submit either electronic or
written comments on the collection of
information by December 31, 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 December 31,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
PO 00000
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Number of
responses per
respondent
Average
burden per
response
(in hours)
190
1
7/60
10
1
7/60
at the end of December 31, 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
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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–
2012–N–0873 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Bar Code
Label Requirement for Human Drug and
Biological Products.’’ 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
VerDate Sep<11>2014
20:30 Oct 31, 2018
Jkt 247001
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
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)
PO 00000
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54931
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.
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 health care 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 health care 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
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.
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 2 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.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / 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
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: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23910 Filed 10–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 of
Environmental Health Sciences Special
Emphasis Panel Review of NIEHS K08, K23,
K24, and K25 Applications.
Date: November 13, 2018.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Science, Keystone Building, 530 Davis
Drive, Room 2164, Research Triangle Park,
NC 27709 (Telephone Conference Call).
Contact Person: Janice B. Allen, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Science, 530 Davis Drive, Room 3170
B, Research Triangle Park, NC 27709, (919)
541–7556, allen9@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel Review of NIEHS
Revolutionizing Innovative, Visionary
VerDate Sep<11>2014
20:30 Oct 31, 2018
Jkt 247001
Environmental Health Research (RIVER)
APPLICATIONS.
Date: November 15, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Marriott Chapel Hill,
01 Erwin Road, Chapel Hill, NC 27514.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 919/541–0670, worth@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel NIH/NIEHS E-Learning for
HAZMAT and Emergency Response.
Date: November 19, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health
Keystone Building, 530 Davis Drive, Room
2164, Research Triangle Park, NC 27709
(Telephone Conference Call).
Contact Person: Laura A. Thomas, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, Research Triangle Park, NC
27709, 919–541–2824, laura.thomas@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 26, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–23856 Filed 10–31–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 Scientific
Review Special Emphasis Panel; PAR Panel:
Shared Instrumentation: Interdisciplinary
Molecular Sciences and Technologies (S10).
Date: November 27, 2018.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6046B,
MSC 7892, Bethesda, MD 20892, 301–408–
9655, gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Nephrology
Small Business Review.
Date: November 27, 2018.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Atul Sahai, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188,
MSC 7818, Bethesda, MD 20892, 301–435–
1198, sahaia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Chemosensory Systems,
Neurotoxicology and Alcohol.
Date: November 27, 2018.
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]]>Agencies
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Notices]
[Pages 54930-54932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23910]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0873]
Agency Information Collection Activities; Proposed Collection;
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 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 bar code label requirements for human drug
and biological products.
DATES: Submit either electronic or written comments on the collection
of information by December 31, 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 December 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 31, 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
[[Page 54931]]
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-2012-N-0873 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Bar Code Label Requirement for
Human Drug and Biological Products.'' 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 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.
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 health care 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 health care 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 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.
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 2 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 54932]]
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
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21 CFR 201.25(d)................................................... 2 1 2 24 48
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\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: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23910 Filed 10-31-18; 8:45 am]
BILLING CODE 4164-01-P
