83 FR 54930 - 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 83, Issue 212 (November 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 212 (November 1, 2018)
| Page Range | 54930-54932 | |
| FR Document | 2018-23910 |
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)] [Notices] [Pages 54930-54932] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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
![54930 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Notices
e.g., permitting electronic submission of the Secretary of the Department of provision, CDC divided the total
responses; and Health and Human Services to make anticipated reporting burden between
(e) Assess information collection and enforce regulations necessary to 70.11 and 70.4 in the accompanying
costs. prevent the introduction, transmission, Paperwork Reduction Act section of the
To request additional information on or spread of communicable diseases rule, assuming that aircraft would report
the proposed project or to obtain a copy from foreign countries into the United most cases of ill people and deaths to
of the information collection plan and States, or from one State or possession CDC, with some airlines and other
instruments, call (404) 639–7570 or into any other State or possession. CDC conveyances reporting still to local
send an email to omb@cdc.gov. Direct administers regulations pertaining to public health authorities. For reports of
written comments and/or suggestions interstate control of communicable ill persons or death on a conveyance
regarding the items contained in this diseases (42 CFR part 70), and sections engaged in interstate traffic, the
notice to the Attention: CDC Desk 42 CFR parts 70.4 and 70.11 include requested burden is approximately 23
Officer, Office of Management and requirements for reports of ill persons or hours. This total is estimated from 200
Budget, 725 17th Street NW, death if occurring during interstate respondents submitting domestic
Washington, DC 20503 or by fax to (202) travel. reports of death or communicable
395–5806. Provide written comments The intended use of the information disease a year, with an average burden
within 30 days of notice publication. is to ensure that CDC can assess and of 7 minutes per report. The only
Proposed Project respond to reports of ill persons or requested change to the approved data
Report of Illness or Death: Interstate death that occur on conveyances collection is a change in title from
Travel of Persons (42 CFR part 70)— engaged in interstate travel, and assist ‘‘Restriction on Travel of Persons (42
Revision—National Center for Emerging state and local health authorities if an CFR part 70)’’ to ‘‘Report of Illness or
and Zoonotic Infectious Diseases illness or death occurs that poses a risk Death: Interstate Travel of Persons (42
(NCEZID), Centers for Disease Control to public health. Generally, the primary CFR part 70)’’. This results in two rows
and Prevention (CDC). source of this information is aircraft in the burden table, but with no
traveling within the United States. additional burden. The estimated
Background and Brief Description In 2017, CDC finalized the Control of annual Burden Hours are 23. There is no
Section 361 of the Public Health Communicable Disease regulations (42 cost to respondents other than their
Service Act (42 U.S.C. 264) authorizes CFR 70 and 71). With this new time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per
Form name responses per
respondents respondents response
respondent (in hours)
Pilot in command .................... 42 CFR 70.11 Report of death or illness onboard aircraft 190 1 7/60
operated by airline.
Master of vessel or person in 42 CFR 70.4 Report by the master of a vessel or person 10 1 7/60
charge of conveyance. in charge of conveyance of the incidence of a commu-
nicable disease occurring while in interstate travel.
Jeffrey M. Zirger announcing an opportunity for public at the end of December 31, 2018.
Acting Lead, Information Collection Review comment on the proposed collection of Comments received by mail/hand
Office, Office of Scientific Integrity, Office certain information by the Agency. delivery/courier (for written/paper
of Science, Centers for Disease Control and Under the Paperwork Reduction Act of submissions) will be considered timely
Prevention. 1995 (PRA), Federal Agencies are if they are postmarked or the delivery
[FR Doc. 2018–23861 Filed 10–31–18; 8:45 am] required to publish notice in the service acceptance receipt is on or
BILLING CODE 4163–18–P Federal Register concerning each before that date.
proposed collection of information,
including each proposed extension of an Electronic Submissions
DEPARTMENT OF HEALTH AND existing collection of information, and Submit electronic comments in the
HUMAN SERVICES to allow 60 days for public comment in following way:
response to the notice. This notice • Federal eRulemaking Portal:
Food and Drug Administration solicits comments on bar code label https://www.regulations.gov. Follow the
[Docket No. FDA–2012–N–0873] requirements for human drug and instructions for submitting comments.
biological products. Comments submitted electronically,
Agency Information Collection DATES: Submit either electronic or including attachments, to https://
Activities; Proposed Collection; written comments on the collection of www.regulations.gov will be posted to
Comment Request; Bar Code Label information by December 31, 2018. the docket unchanged. Because your
Requirement for Human Drug and ADDRESSES: You may submit comments comment will be made public, you are
daltland on DSKBBV9HB2PROD with NOTICES
Biological Products as follows. Please note that late, solely responsible for ensuring that your
AGENCY: Food and Drug Administration, untimely filed comments will not be comment does not include any
HHS. considered. Electronic comments must confidential information that you or a
ACTION: Notice. be submitted on or before December 31, third party may not wish to be posted,
2018. The https://www.regulations.gov such as medical information, your or
SUMMARY: The Food and Drug electronic filing system will accept anyone else’s Social Security number, or
Administration (FDA or Agency) is comments until 11:59 p.m. Eastern Time confidential business information, such
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![54932 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Notices
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
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 Environmental Health Research (RIVER) DEPARTMENT OF HEALTH AND
collection since our last request for APPLICATIONS. HUMAN SERVICES
OMB approval, we have made no Date: November 15, 2018.
adjustments to our burden estimate. Time: 8:00 a.m. to 5:00 p.m. National Institutes of Health
Agenda: To review and evaluate grant
Dated: October 29, 2018. Center for Scientific Review; Notice of
applications.
Leslie Kux, Place: Residence Inn Marriott Chapel Hill, Closed Meetings
Associate Commissioner for Policy. 01 Erwin Road, Chapel Hill, NC 27514.
[FR Doc. 2018–23910 Filed 10–31–18; 8:45 am]
Pursuant to section 10(d) of the
Contact Person: Leroy Worth, Ph.D.,
Federal Advisory Committee Act, as
BILLING CODE 4164–01–P Scientific Review Officer, Scientific Review
amended, notice is hereby given of the
Branch, Division of Extramural Research and
following meetings.
Training, National Institute of Environmental
DEPARTMENT OF HEALTH AND The meetings will be closed to the
Health Sciences, P.O. Box 12233, MD EC–30/
HUMAN SERVICES public in accordance with the
Room 3171, Research Triangle Park, NC
provisions set forth in sections
27709, 919/541–0670, worth@niehs.nih.gov.
National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Name of Committee: National Institute of as amended. The grant applications and
National Institute of Environmental Environmental Health Sciences Special the discussions could disclose
Health Sciences; Notice of Closed Emphasis Panel NIH/NIEHS E-Learning for confidential trade secrets or commercial
Meetings HAZMAT and Emergency Response. property such as patentable material,
Date: November 19, 2018. and personal information concerning
Pursuant to section 10(d) of the Time: 11:00 a.m. to 3:00 p.m. individuals associated with the grant
Federal Advisory Committee Act, as Agenda: To review and evaluate grant
applications, the disclosure of which
amended, notice is hereby given of the applications.
would constitute a clearly unwarranted
Place: NIEHS/National Institutes of Health
following meetings. invasion of personal privacy.
Keystone Building, 530 Davis Drive, Room
The meetings will be closed to the 2164, Research Triangle Park, NC 27709 Name of Committee: Center for Scientific
public in accordance with the (Telephone Conference Call). Review Special Emphasis Panel; PAR Panel:
provisions set forth in sections Shared Instrumentation: Interdisciplinary
Contact Person: Laura A. Thomas, Ph.D.,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Molecular Sciences and Technologies (S10).
Scientific Review Officer, Scientific Review Date: November 27, 2018.
as amended. The grant applications and Branch, Division of Extramural Research and Time: 9:00 a.m. to 8:00 p.m.
the discussions could disclose Training, National Institute of Environmental Agenda: To review and evaluate grant
confidential trade secrets or commercial Health Sciences, Research Triangle Park, NC applications.
property such as patentable material, 27709, 919–541–2824, laura.thomas@ Place: National Institutes of Health, 6701
and personal information concerning nih.gov. Rockledge Drive, Bethesda, MD 20892
individuals associated with the grant (Catalogue of Federal Domestic Assistance (Virtual Meeting).
applications, the disclosure of which Contact Person: Alexander Gubin, Ph.D.,
Program Nos. 93.115, Biometry and Risk
would constitute a clearly unwarranted Scientific Review Officer, Center for
Estimation—Health Risks from Scientific Review, National Institutes of
invasion of personal privacy. Environmental Exposures; 93.142, NIEHS Health, 6701 Rockledge Drive, Room 6046B,
Name of Committee: National Institute of Hazardous Waste Worker Health and Safety MSC 7892, Bethesda, MD 20892, 301–408–
Environmental Health Sciences Special Training; 93.143, NIEHS Superfund 9655, gubina@csr.nih.gov.
Emphasis Panel Review of NIEHS K08, K23, Hazardous Substances—Basic Research and Name of Committee: Center for Scientific
K24, and K25 Applications. Education; 93.894, Resources and Manpower Review Special Emphasis Panel; Nephrology
Date: November 13, 2018. Development in the Environmental Health Small Business Review.
Time: 11:00 a.m. to 2:00 p.m. Sciences; 93.113, Biological Response to Date: November 27, 2018.
Agenda: To review and evaluate grant Environmental Health Hazards; 93.114, Time: 9:00 a.m. to 6:00 p.m.
applications. Agenda: To review and evaluate grant
Applied Toxicological Research and Testing,
Place: National Institute of Environmental applications.
Health Science, Keystone Building, 530 Davis National Institutes of Health, HHS)
Place: National Institutes of Health, 6701
Drive, Room 2164, Research Triangle Park, Dated: October 26, 2018. Rockledge Drive, Bethesda, MD 20892
NC 27709 (Telephone Conference Call). Natasha M. Copeland, (Virtual Meeting).
Contact Person: Janice B. Allen, Ph.D., Contact Person: Atul Sahai, Ph.D.,
Scientific Review Officer, Scientific Review Program Analyst, Office of Federal Advisory Scientific Review Officer, Center for
Branch, Division of Extramural Research and Committee Policy. Scientific Review, National Institutes of
daltland on DSKBBV9HB2PROD with NOTICES
Training, National Institute of Environmental [FR Doc. 2018–23856 Filed 10–31–18; 8:45 am] Health, 6701 Rockledge Drive, Room 2188,
Health Science, 530 Davis Drive, Room 3170 BILLING CODE 4140–01–P MSC 7818, Bethesda, MD 20892, 301–435–
B, Research Triangle Park, NC 27709, (919) 1198, sahaia@csr.nih.gov.
541–7556, allen9@niehs.nih.gov. Name of Committee: Center for Scientific
Name of Committee: National Institute of Review Special Emphasis Panel; Member
Environmental Health Sciences Special Conflict: Chemosensory Systems,
Emphasis Panel Review of NIEHS Neurotoxicology and Alcohol.
Revolutionizing Innovative, Visionary Date: November 27, 2018.
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Document Created: 2018-11-01 01:05:18
Document Modified: 2018-11-01 01:05:18
| 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 December 31, 2018. | |
| 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] | |
| FR Citation | 83 FR 54930 |
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