80 FR 77637 - Agency Information Collection Activities; Proposed Collection; 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 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77637-77638 | |
| FR Document | 2015-31402 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77637-77638] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31402] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-0873] 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) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 the bar code label requirements for human drug and biological products. DATES: Submit either electronic or written comments on the collection of information by February 16, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. [[Page 77638]] Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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: (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), we issued a final rule that required human drug product and biological product labels to have bar codes. The rule required bar codes on most human prescription drug products and on over-the-counter (OTC) drug products that are dispensed pursuant to an order and commonly used in health care facilities. The rule also required machine-readable information on blood and blood components. For human prescription drug products and OTC drug products that are dispensed pursuant to 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 machine-readable information in a format approved by the Center for Biologics Evaluation and Research Director as blood centers have generally agreed upon the information to be encoded on the label. The rule is intended to help 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. Most of the information collection burden resulting from the final rule, as calculated in table 1 of the final rule (69 FR at 9149), was a one-time burden that does not occur after the rule's compliance date of April 26, 2006. In addition, some of the information collection burden estimated in the final rule is now covered in other OMB approved information collection packages for FDA. However, parties may continue to seek an exemption from the bar code requirement under certain, limited circumstances. Section 201.25(d) (21 CFR 201.25(d)) requires submission of a written request for an exemption and describes the contents of such requests. Based on the number of exemption requests we have received, we estimate that approximately 2 exemption requests may be submitted annually, and that each exemption request will require 24 hours to complete. This would result in an annual reporting burden of 48 hours. 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: December 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31402 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77637
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND Written/Paper Submissions
796–1015. HUMAN SERVICES Submit written/paper submissions as
SUPPLEMENTARY INFORMATION: follows:
Food and Drug Administration • Mail/Hand delivery/Courier (for
I. Background [Docket No. FDA–2012–0873] written/paper submissions): Division of
FDA is announcing the availability of Dockets Management (HFA–305), Food
Agency Information Collection and Drug Administration, 5630 Fishers
a draft guidance for industry entitled Activities; Proposed Collection;
‘‘Head Lice Infestation: Developing Lane, Rm. 1061, Rockville, MD 20852.
Comment Request; Bar Code Label • For written/paper comments
Drugs for Topical Treatment.’’ The Requirement for Human Drug and submitted to the Division of Dockets
purpose of this draft guidance is to Biological Products Management, FDA will post your
assist sponsors in the clinical
AGENCY: Food and Drug Administration, comment, as well as any attachments,
development of drugs for the treatment
HHS. except for information submitted,
of head lice infestation. This draft
ACTION: Notice. marked and identified, as confidential,
guidance addresses the Agency’s current
if submitted as detailed in
thinking regarding the overall
SUMMARY: The Food and Drug ‘‘Instructions.’’
development program and clinical trial
Administration (FDA) is announcing an Instructions: All submissions received
designs of drugs to support approval of
opportunity for public comment on the must include the Docket No. FDA–
an indication for topical treatment of
proposed collection of certain 2012–N–0873 for ‘‘Agency Information
head lice infestation. The information
information by the Agency. Under the Collection Activities: Proposed
presented will help sponsors plan
Paperwork Reduction Act of 1995 (the Collection; Comment Request; Bar Code
clinical trials, design clinical protocols,
PRA), Federal Agencies are required to Label Requirement for Human Drug and
and conduct and appropriately monitor
publish notice in the Federal Register Biological Products’’. Received
clinical trials.
concerning each proposed collection of comments will be placed in the docket
This draft guidance is being issued information, including each proposed and, except for those submitted as
consistent with FDA’s good guidance extension of an existing collection of ‘‘Confidential Submissions,’’ publicly
practices regulation (21 CFR 10.115). information, and to allow 60 days for viewable at
The draft guidance, when finalized, will public comment in response to the http://www.regulations.gov or at the
represent the current thinking of FDA notice. This notice solicits comments on Division of Dockets Management
on developing drugs for the topical the bar code label requirements for between 9 a.m. and 4 p.m., Monday
treatment of head lice infestation. It human drug and biological products. through Friday.
does not establish any rights for any DATES: Submit either electronic or • Confidential Submissions—To
person and is not binding on FDA or the written comments on the collection of submit a comment with confidential
public. You can use an alternative information by February 16, 2016. information that you do not wish to be
approach if it satisfies the requirements made publicly available, submit your
ADDRESSES: You may submit comments
of the applicable statutes and comments only as a written/paper
as follows:
regulations. submission. You should submit two
Electronic Submissions copies total. One copy will include the
II. The Paperwork Reduction Act of
1995 Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
This guidance refers to previously • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
approved collections of information that www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
are subject to review by the Office of instructions for submitting comments. Agency will review this copy, including
Management and Budget (OMB) under Comments submitted electronically, the claimed confidential information, in
the Paperwork Reduction Act of 1995 including attachments, to http:// its consideration of comments. The
(44 U.S.C. 3501–3520). The collections www.regulations.gov will be posted to second copy, which will have the
of information in 21 CFR parts 312 and the docket unchanged. Because your claimed confidential information
314 have been approved under OMB comment will be made public, you are redacted/blacked out, will be available
control numbers 0910–0014 and 0910– solely responsible for ensuring that your for public viewing and posted on http://
0001, respectively. The collections of comment does not include any www.regulations.gov. Submit both
information for prescription drug confidential information that you or a copies to the Division of Dockets
product labeling in 21 CFR 201.56 and third party may not wish to be posted, Management. If you do not wish your
201.57 have been approved under OMB such as medical information, your or name and contact information to be
control number 0910–0572. anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
III. Electronic Access sheet and not in the body of your
as a manufacturing process. Please note
Persons with access to the Internet that if you include your name, contact comments and you must identify this
may obtain the document at either information, or other information that information as ‘‘confidential.’’ Any
http://www.fda.gov/Drugs/Guidance identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ComplianceRegulatoryInformation/
Guidances/default.htm or http:// posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
www.regulations.gov. • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
Dated: December 8, 2015. do not wish to be made available to the comments to public dockets, see 80 FR
Leslie Kux, public, submit the comment as a 56469, September 18, 2015, or access
Associate Commissioner for Policy. written/paper submission and in the the information at: http://www.fda.gov/
[FR Doc. 2015–31406 Filed 12–14–15; 8:45 am] manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). default.htm.
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![77638 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
Docket: For access to the docket to With respect to the following components, the rule specifies the
read background documents or the collection of information, FDA invites minimum contents of the machine-
electronic and written/paper comments comments on: (1) Whether the proposed readable information in a format
received, go to http:// collection of information is necessary approved by the Center for Biologics
www.regulations.gov and insert the for the proper performance of FDA’s Evaluation and Research Director as
docket number, found in brackets in the functions, including whether the blood centers have generally agreed
heading of this document, into the information will have practical utility; upon the information to be encoded on
‘‘Search’’ box and follow the prompts (2) the accuracy of FDA’ s estimate of the label. The rule is intended to help
and/or go to the Division of Dockets the burden of the proposed collection of reduce the number of medication errors
Management, 5630 Fishers Lane, Rm. information, including the validity of in hospitals and other health care
1061, Rockville, MD 20852. the methodology and assumptions used; settings by allowing health care
FOR FURTHER INFORMATION CONTACT: FDA (3) ways to enhance the quality, utility, professionals to use bar code scanning
PRA Staff, Office of Operations, Food and clarity of the information to be equipment to verify that the right drug
and Drug Administration, 8455 collected; and (4) ways to minimize the (in the right dose and right route of
Colesville Rd., COLE–14526, Silver burden of the collection of information administration) is being given to the
Spring, MD 20993–0002, PRAStaff@ on respondents, including through the right patient at the right time.
fda.hhs.gov. use of automated collection techniques,
when appropriate, and other forms of Most of the information collection
SUPPLEMENTARY INFORMATION: Under the information technology. burden resulting from the final rule, as
PRA (44 U.S.C. 3501–3520) Federal calculated in table 1 of the final rule (69
Agencies must obtain approval from the Bar Code Label Requirement for FR at 9149), was a one-time burden that
Office of Management and Budget Human Drug and Biological Products does not occur after the rule’s
(OMB) for each collection of OMB Control Number 0910–0537— compliance date of April 26, 2006. In
information they conduct or sponsor. Extension addition, some of the information
‘‘Collection of information’’ is defined In the Federal Register of February collection burden estimated in the final
in 44 U.S.C. 3502(3) and 5 CFR 26, 2004 (69 FR 9120), we issued a final rule is now covered in other OMB
1320.3(c) and includes Agency requests rule that required human drug product approved information collection
or requirements that members of the and biological product labels to have bar packages for FDA. However, parties may
public submit reports, keep records, or codes. The rule required bar codes on continue to seek an exemption from the
provide information to a third party. most human prescription drug products bar code requirement under certain,
Section 3506(c)(2)(A) of the PRA (44 and on over-the-counter (OTC) drug limited circumstances. Section
U.S.C. 3506(c)(2)(A)) requires Federal products that are dispensed pursuant to 201.25(d) (21 CFR 201.25(d)) requires
Agencies to provide a 60-day notice in an order and commonly used in health submission of a written request for an
the Federal Register concerning each care facilities. The rule also required exemption and describes the contents of
proposed collection of information, machine-readable information on blood such requests. Based on the number of
including each proposed extension of an and blood components. For human exemption requests we have received,
existing collection of information, prescription drug products and OTC we estimate that approximately 2
before submitting the collection to OMB drug products that are dispensed exemption requests may be submitted
for approval. To comply with this pursuant to an order and commonly annually, and that each exemption
requirement, FDA is publishing notice used in health care facilities, the bar request will require 24 hours to
of the proposed collection of code must contain the NDC number for complete. This would result in an
information set forth in this document. the product. For blood and blood annual reporting burden of 48 hours.
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: December 7, 2015. DEPARTMENT OF HEALTH AND the regulatory review period for
Leslie Kux, HUMAN SERVICES TRIVASCULAR OVATION
Associate Commissioner for Policy. ABDOMINAL STENT GRAFT SYSTEM
Food and Drug Administration and is publishing this notice of that
[FR Doc. 2015–31402 Filed 12–14–15; 8:45 am]
[Docket No. FDA–2013–E–1694] determination as required by law. FDA
BILLING CODE 4164–01–P
has made the determination because of
Determination of Regulatory Review the submission of an application to the
Period for Purposes of Patent Director of the U.S. Patent and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Extension; Trivascular Ovation Trademark Office (USPTO), Department
Abdominal Stent Graft System of Commerce, for the extension of a
patent which claims that medical
AGENCY: Food and Drug Administration, device.
HHS.
ACTION: Notice. DATES: Anyone with knowledge that any
of the dates as published (see the
SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION section) are
Administration (FDA) has determined incorrect may submit either electronic
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Document Created: 2018-03-02 09:15:48
Document Modified: 2018-03-02 09:15:48
| 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 | Submit either electronic or written comments on the collection of information by February 16, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 77637 |
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