Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products, 28856-28857 [2013-11630]

Download as PDF 28856 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers Total .............................................................................. 1 There Number of records per recordkeeper Total annual records Average burden per recordkeeping ........................ 21 CFR Section ........................ ........................ ........................ Total hours 29,000 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1 §§ 107.10(a) and 107.20 ...................................................... tkelley on DSK3SPTVN1PROD with NOTICES 1 There Number of disclosures per respondent Number of respondents 21 CFR Section 5 Total annual disclosures 13 65 Average burden per disclosure Total hours 8 520 are no capital costs or operating and maintenance costs associated with this collection of information. In compiling these estimates, we consulted our records of the number of infant formula submissions received in the past. All infant formula submissions may be provided to us in electronic format. The hours per response reporting estimates are based on our experience with similar programs and information received from industry. We estimate that we will receive 13 reports from 5 manufacturers annually under section 412(d) of the FD&C Act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. We also estimate that we will receive one notification under § 106.120(b). The notification is expected to take 4 hours per response, for a total of 4 hours. For exempt infant formula, we estimate that we will receive two reports from three manufacturers annually under §§ 107.50(b)(3) and (b)(4), for a total annual response of six reports. Each report is estimated to take 4 hours per response for a total of 24 hours. We also estimate that we will receive one notification annually under § 107.50(e)(2) and that the notification will take 4 hours to prepare. We estimate that 5 firms will expend approximately 20,000 hours per year to fully satisfy the recordkeeping requirements in § 106.100 and that 3 firms will expend approximately 9,000 hours per year to fully satisfy the recordkeeping requirements in § 107.50(c)(3). We estimate compliance with our labeling requirements in §§ 107.10(a) and 107.20 requires 520 hours annually by 5 manufacturers. Dated: May 9, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–11631 Filed 5–15–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 18:13 May 15, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES collection of information to OMB for review and clearance. Food and Drug Administration Bar Code Label Requirement for Human Drug and Biological Products— (OMB Control Number 0910–0537)— Extension [Docket No. FDA–2012–N–0873] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 17, 2013. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0537. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 In the Federal Register of February 26, 2004 (69 FR 9120), we issued regulations 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 under 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 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 rule specifies the minimum contents of the machinereadable 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 9120 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 E:\FR\FM\16MYN1.SGM 16MYN1 28857 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices 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. In the Federal Register of August 17, 2012 (77 FR 49818), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden for this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section § 201.25(d) ................................................................. 1 There [FR Doc. 2013–11630 Filed 5–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, HHS. ACTION: Notice The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Total annual responses 1 2 2 Average burden per response 24 Total hours 48 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 10, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Number of responses per respondent A Diagnostic Kit for Assessing Exposure or Infection by the Koala Family of Retroviruses Description of Technology: Inventors at the NIH have discovered a new family VerDate Mar<15>2010 18:13 May 15, 2013 Jkt 229001 of infectious koala retroviruses that are correlated with the development of malignant neoplasias, including lymphomas and leukemias. This invention relates to a diagnostic kit for assessing exposure or infection by a koala retrovirus. The kit consists of specific primers and probes for the detection of three distinct subtypes of infectious koala retrovirus and may be useful in various species, including humans, primates, and koalas. Infectious koala retroviruses have been shown to infect human cells in culture, though the health implications in humans have not yet been fully determined. Potential Commercial Applications: • A diagnostic kit for assessing exposure or infection by the koala family of retroviruses • May be useful in monitoring effectiveness of antiretroviral treatment Competitive Advantages: Detection of newly discovered subtypes of infectious koala retroviruses. Development Stage: • Early-stage • In vitro data available Inventors: Maribeth V. Eiden (NIMH), Wenqin Xu (NIMH), William M. Switzer (CDC), HaoQiang Zheng (CDC) Intellectual Property: HHS Reference No. E–053–2013/0—US Application No. 61/784,763 filed 14 Mar 2013 Licensing Contact: Charlene Sydnor, Ph.D.; 301–435–4689; sydnorc@mail.nih.gov Collaborative Research Opportunity: The National Institute of Mental Health is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize A Diagnostic Kit for Assessing Exposure or Infection by the Koala Family of Retroviruses. For collaboration opportunities, please contact Suzanne L. Winfield, Ph.D. at winfiels@mail.nih.gov or 301–402–4324. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Retroviral Vector Packaging Cell Lines and Purification Methods for Gene Therapy Description of Technology: This invention relates to a novel gammaretroviral vector packaging cell line and method of producing gammaretroviral vectors suitable for gene therapy. The described vectors may contain the gibbon ape leukemia virus (GALV) envelope with a CD11D8 epitope tag enabling their purification on a monoclonal antibody conjugated column. These vectors have several advantages over existing systems, including a broader host range, higher infectivity, and lower potential for replication. Further, purification of retroviral vector particles via an epitope tag may remove cellular components and debris toxic to target cells and tissues, providing a safer method of delivery for patients receiving gene therapy. Potential Commercial Applications: Retroviral vector particles for gene therapy. Competitive Advantages: • Broader host range • Higher infectivity • Lower potential for replication • Decreased toxicity after purification Development Stage: • Early-stage • In vitro data available Inventors: Maribeth V. Eiden and Wenqin Xu (NIMH) Intellectual Property: HHS Reference No. E–036–2013/0—US Application No. 61/759,516 filed 01 Feb 2013 Licensing Contact: Charlene Sydnor, Ph.D.; 301–435–4689; sydnorc@mail.nih.gov Collaborative Research Opportunity: The National Institute of Mental Health is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28856-28857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11630]


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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 June 
17, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0537. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Bar Code Label Requirement for Human Drug and Biological Products--(OMB 
Control Number 0910-0537)--Extension

    In the Federal Register of February 26, 2004 (69 FR 9120), we 
issued regulations 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 under 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 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 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 9120 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

[[Page 28857]]

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.
    In the Federal Register of August 17, 2012 (77 FR 49818), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                                     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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   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: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11630 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P