81 FR 46940 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

Page Range		46940-46941
FR Document		2016-17044

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.

Federal Register, Volume 81 Issue 138 (Tuesday, July 19, 2016)

[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46940-46941]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17044]


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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 [email protected]. 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, [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 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

46940 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices

generated for submission to the Dated: July 13, 2016. final rule that requires human drug
regulatory authorities. Leslie Kux, product and biological product labels to
Since the E2C(R2) draft guidance was Associate Commissioner for Policy. have bar codes. Specifically, the rule
made available in 2012, ICH has [FR Doc. 2016–17009 Filed 7–18–16; 8:45 am] requires bar codes on most human
identified questions linked to the BILLING CODE 4164–01–P prescription drug products and on over-
interpretation and application of the the-counter (OTC) drug products that
E2C(R2) guidance. The E2C(R2) Q&A are dispensed under an order and
DEPARTMENT OF HEALTH AND commonly used in health care facilities.
guidance is intended to clarify questions
HUMAN SERVICES The rule also requires machine-readable
relating to implementation of the
E2C(R2) guidance. information on blood and blood
Food and Drug Administration
components. For human prescription
These guidances are being issued [Docket No. FDA–2012–N–0873] drug products and OTC drug products
consistent with FDA’s good guidance
that are dispensed under an order and
practices regulation (21 CFR 10.115). Agency Information Collection
commonly used in health care facilities,
The guidances represent the current Activities; Submission for Office of
the bar code must contain the NDC
thinking of FDA on the E2C(R2) PBRER. Management and Budget Review;
Comment Request; Bar Code Label number for the product. For blood and
They do not establish any rights for any
Requirement for Human Drug and blood components, the rule specifies the
person and are not binding on FDA or
Biological Products minimum contents of the label in a
the public. You can use an alternative
format that is machine-readable and
approach if it satisfies the requirements AGENCY: Food and Drug Administration, approved for use by the Director, Center
of the applicable statutes and HHS. for Biologics Evaluation and Research.
regulations. ACTION: Notice. We believe the rule helps to reduce the
II. The Paperwork Reduction Act of SUMMARY: The Food and Drug number of medication errors in
1995 Administration (FDA) is announcing hospitals and other health care settings
that a proposed collection of by allowing health care professionals to
These guidances refer to previously use bar code scanning equipment to
information has been submitted to the
approved collections of information verify that the right drug (in the right
Office of Management and Budget
found in FDA regulations. These (OMB) for review and clearance under dose and right route of administration)
collections of information are subject to the Paperwork Reduction Act of 1995. is being given to the right patient at the
review by the Office of Management and DATES: Fax written comments on the right time.
Budget (OMB) under the Paperwork collection of information by August 18, While most of the information
Reduction Act of 1995 (PRA) (44 U.S.C. 2016. collection burdens created by the final
3501–3520). The collection of ADDRESSES: To ensure that comments on rule have now been incorporated into
information in the ‘‘Guidance on the information collection are received, currently approved information
Reporting in Accordance with OMB recommends that written collections supporting the applicable
International Council for comments be faxed to the Office of regulations, respondents to the
Harmonisation—Periodic Benefit-Risk Information and Regulatory Affairs, collection may continue to seek an
Evaluation Report (E2C(R2)) and OMB, Attn: FDA Desk Officer, FAX: exemption from the bar code label
Providing Waiver-Related Materials’’ 202–395–7285, or emailed to oira_
requirement under § 201.25(d) (21 CFR
has been approved under OMB control submission@omb.eop.gov. All
201.25(d)). Section 201.25(d) requires
number 0910–0771. The guidances also comments should be identified with the
OMB control number 0910–0537. Also submission of a written request for an
reference other collections of
include the FDA docket number found exemption and describes the
information. The collection of
in brackets in the heading of this information that must be included in
information in 21 CFR 314.80 has been
document. such a request. Based on the number of
approved under OMB control number
exemption requests we have received
0910–0230, and the collection of FOR FURTHER INFORMATION CONTACT: FDA
previously, we estimate that
information in 21 CFR 600.80 has been PRA Staff, Office of Operations, Food
approximately 2 exemption requests
approved under OMB control number and Drug Administration, Three White
Flint North 10A–12M, 11601 will be submitted annually and that
0910–0308.
Landsdown Street, North Bethesda, MD each exemption request will require 24
III. Electronic Access 20852, PRAStaff@fda.hhs.gov. hours to complete. This results in an
SUPPLEMENTARY INFORMATION: In
annual reporting burden of 48 hours, as
Persons with access to the Internet reflected below in Table 1.
may obtain the document at http:// compliance with 44 U.S.C. 3507, FDA
www.regulations.gov, http:// has submitted the following proposed In the Federal Register of December
www.fda.gov/Drugs/Guidance collection of information to OMB for 15, 2015 (80 FR 77637) FDA published
review and clearance. a 60-day notice requesting public
ComplianceRegulatoryInformation/
Guidances/default.htm, or http:// Bar Code Label Requirement for comment on the proposed collection of
www.fda.gov/BiologicsBloodVaccines/ Human Drug Products and Blood; OMB information. No comments were
GuidanceComplianceRegulatory Control No. 0910–0537—Extension received.
mstockstill on DSK3G9T082PROD with NOTICES

Information/Guidances/default.htm. In the Federal Register of February We estimate the burden of this
26, 2004 (69 FR 9120), FDA issued a collection of information as follows:

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Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices 46941

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent 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. Participation’’ heading, the first or call the HRSA Information Collection
Leslie Kux, sentence is corrected to read Clearance Officer at (301) 443–1984.
Associate Commissioner for Policy. ‘‘Registration information, the agenda, SUPPLEMENTARY INFORMATION: When
[FR Doc. 2016–17044 Filed 7–18–16; 8:45 am] and additional background materials submitting comments or requesting
BILLING CODE 4164–01–P
can be found at http://www.fda.gov/ information, please include the
NewsEvents/ information request collection title for
MeetingsConferencesWorkshops/ reference.
DEPARTMENT OF HEALTH AND ucm506658.htm. Information Collection Request Title:
HUMAN SERVICES Dated: July 13, 2016. Scholarships for Disadvantaged
Leslie Kux, Students (SDS) Program.
Food and Drug Administration OMB No. 0915–0149—Revision.
Associate Commissioner for Policy. Abstract: The program specific form
[Docket No. FDA–2016–N–0001] [FR Doc. 2016–17015 Filed 7–18–16; 8:45 am] for the SDS program has been revised to
Pediatric Clinical Investigator Training
BILLING CODE 4164–01–P reflect a change in the order of the fields
Workshop; Correction only. Fields K (Public or Non Profit
Institution) and H (Point of Contact)
AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND have been moved to fields A and B
HHS. HUMAN SERVICES respectively. Now Field A is Public or
ACTION: Notice; Correction. Non Profit Institution and Field B is
Health Resources and Services
Point of Contact. All other fields
SUMMARY: The Food and Drug Administration
remained in sequence but were renamed
Administration (FDA) is correcting a with the appropriate letter order.
notice that appeared in the Federal Agency Information Collection
Activities: Proposed Collection: Public Need and Proposed Use of the
Register on June 16, 2016 (81 FR 39271). Information: The purpose of the SDS
The document announced a ‘‘Pediatric Comment Request—Scholarships for
Disadvantaged Students Program Program is to provide funds to eligible
Clinical Investigator Training’’ schools to provide scholarships to full-
workshop and contained an incorrect AGENCY: Health Resources and Services time, financially needy students from
Web link for registration and an Administration, HHS. disadvantaged backgrounds enrolled in
incorrect Web link for more information health professions programs. To qualify
ACTION: Notice.
on the workshop. This document for participation in the SDS program, a
corrects those errors. SUMMARY: In compliance with the school must be carrying out a program
FOR FURTHER INFORMATION CONTACT: requirement for opportunity for public for recruiting and retaining students
Terrie L. Crescenzi, Office of Pediatric comment on proposed data collection from disadvantaged backgrounds,
Therapeutics, Food and Drug projects (Section 3506(c) (2) (A) of the including students who are members of
Administration, 10903 New Hampshire Paperwork Reduction Act of 1995), the racial and ethnic minority groups
Ave., Silver Spring, MD 20993–0002, Health Resources and Services (section 737(d)(1)(B) of the Public
terrie.crescenzi@fda.hhs.gov or Betsy Administration (HRSA) announces Health Service (PHS) Act). A school
Sanford, Office of Pediatric plans to submit an Information must meet the eligibility criteria to
Therapeutics, Food and Drug Collection Request (ICR), described demonstrate that the program has
Administration, 10903 New Hampshire below, to the Office of Management and achieved success based on the number
Ave., Silver Spring, MD 20993–0002, Budget (OMB). Prior to submitting the and/or percentage of disadvantaged
elizabeth.sanford@fda.hhs.gov. ICR to OMB, HRSA seeks comments students who graduate from the school.
SUPPLEMENTARY INFORMATION: In the from the public regarding the burden In awarding SDS funds to eligible
Federal Register of Thursday, June 16, estimate, below, or any other aspect of schools, funding points must be given to
2016, in FR Doc. 2016–14230, on page the ICR. schools based on the proportion of
39272, the following corrections are DATES: Comments on this ICR should be graduating students going into primary
made: received no later than September 19, care, the proportion of underrepresented
1. On page 39272, in the first column, 2016. minority students, and the proportion of
in the first paragraph under the graduates working in medically
‘‘Workshop Attendance and ADDRESSES: Submit your comments to underserved communities (section
Participation’’ heading, the first paperwork@hrsa.gov or mail the HRSA 737(c) of the PHS Act).
sentence is corrected to read ‘‘If you Information Collection Clearance Likely Respondents: The respondents
mstockstill on DSK3G9T082PROD with NOTICES

wish to attend this workshop, visit Officer, Room 10–29, 5600 Fishers Lane, are institutions that will be applying to
https://www.eventbrite.com/e/pediatric- Rockville, MD 20857. the SDS program every four years.
clinical-investigator-training-workshop- FOR FURTHER INFORMATION CONTACT: To Burden Statement: Burden in this
tickets-19708166657. request more information on the context means the time expended by
2. On page 39272, in the first column, proposed project or to obtain a copy of persons to generate, maintain, retain,
in the second paragraph under the the data collection plans and draft disclose, or provide the information
‘‘Workshop Attendance and instruments, email paperwork@hrsa.gov requested. This includes the time

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Document Created: 2016-07-19 01:10:52
Document Modified: 2016-07-19 01:10:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 18, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown Street, North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 46940

81 FR 46940 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration