Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination; Availability, 22887-22888 [2013-08913]

Download as PDF 22887 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Respondents Form name Central Cancer Registries in States, Territories, and the District of Columbia. Standard NPCR CSS Report 38 2 2 Enhanced NPCR Report ....... 10 2 2 Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–08912 Filed 4–16–13; 8:45 am] approval expires on March 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: April 11, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–08906 Filed 4–16–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0867] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On May 8, 2012, the Agency submitted a proposed collection of information entitled ‘‘Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0736. The sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: 16:50 Apr 16, 2013 [Docket No. FDA–2011–D–0104] Guidance for Industry on NonPenicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing CrossContamination; Availability AGENCY: Notice. VerDate Mar<15>2010 Food and Drug Administration Jkt 229001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.’’ This guidance describes the importance of implementing controls to prevent crosscontamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and nonpenicillin beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates and derivatives. Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity. DATES: Submit either electronic or written comments on Agency guidances at any time. SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4314, Silver Spring, MD 20993–0002, 301–796–6972. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP Framework for Preventing CrossContamination.’’ This guidance describes the importance of implementing controls to prevent crosscontamination of finished pharmaceuticals and APIs with nonpenicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and nonpenicillin beta-lactams). Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of nonpenicillin beta-lactams because those compounds pose health risks associated with cross-reactivity. Although the existing current good manufacturing practices (CGMP) regulations require separation of manufacturing facilities to avoid crosscontamination, the only class of products for which the regulations specify particular separation E:\FR\FM\17APN1.SGM 17APN1 22888 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES requirements are penicillins. This guidance explains that, due to the potential health risks of crosscontamination, the Agency expects separation for all classes of beta-lactam drugs, including penicillins as well as non-penicillin beta-lactams. Specifically, FDA recommends that manufacturers establish appropriate separation and control systems designed to prevent two types of contamination: (1) The contamination of a nonpenicillin beta-lactam by any other nonpenicillin beta-lactam and (2) the contamination of any other type of product by a non-penicillin beta-lactam. Accordingly, FDA recommends that the area in which any class of sensitizing beta-lactam is manufactured should be separated from areas in which any other products are manufactured, and should have an independent air handling system. A draft version of this guidance was published in March 2011 as ‘‘NonPenicillin Beta-Lactam Risk Assessment: A CGMP Framework.’’ This final version was revised in response to docket comments to clarify that this guidance does not provide a formal risk assessment, but, rather, describes FDA’s expectations and recommendations for separation strategies to prevent crosscontamination. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on Non-Penicillin BetaLactam Drugs: A CGMP Framework for Preventing Cross-Contamination. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. VerDate Mar<15>2010 16:50 Apr 16, 2013 Jkt 229001 III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: April 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–08913 Filed 4–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. SUMMARY: Information Collection Request Title: Health Care and Other Facilities (OMB No. 0915–0309)—Extension Abstract: The Health Resources and Services Administration’s Health Care PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 and Other Facilities (HCOF) program provides congressionally-directed funds to health-related facilities for construction related activities and/or capital equipment purchases. Awarded facilities are required to provide a periodic (quarterly for construction related projects, annually for equipment only projects) update of the status of the funded project until it is completed. The monitoring period averages about three years, although some projects take up to five years to complete. The information collected from these updates is vital to program management staff to determine whether projects are progressing according to the established timeframes, meeting deadlines established in the Notice of Award, and drawing down funds appropriately. The data collected from the updates is also shared with the Division of Grants Management Operations for their assistance in the overall evaluation of each project’s progress. An electronic form is currently being used for progress reporting for the HCOF program. This form provides awardees access to directly input the required status update information in a timely, consistent, and uniform manner. The electronic form minimizes burden to respondents and informs respondents when there are missing data elements prior to submission. We acknowledge a change in the burden estimate due to close out of old projects. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: E:\FR\FM\17APN1.SGM 17APN1

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[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22887-22888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0104]


Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A 
Current Good Manufacturing Practices Framework for Preventing Cross-
Contamination; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Non-Penicillin Beta-
Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.'' 
This guidance describes the importance of implementing controls to 
prevent cross-contamination of finished pharmaceuticals and active 
pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. 
This guidance also provides information regarding the relative health 
risk of, and the potential for, cross-reactivity in the classes of 
sensitizing beta-lactams (including both penicillins and non-penicillin 
beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates 
and derivatives. Finally, this guidance clarifies that manufacturers 
should generally utilize separate facilities for manufacture of non-
penicillin beta-lactams because those compounds pose health risks 
associated with cross-reactivity.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 4314, Silver Spring, MD 20993-0002, 301-796-6972.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for 
Preventing Cross-Contamination.'' This guidance describes the 
importance of implementing controls to prevent cross-contamination of 
finished pharmaceuticals and APIs with non-penicillin beta-lactam 
drugs. This guidance also provides information regarding the relative 
health risk of, and the potential for, cross-reactivity in the classes 
of sensitizing beta-lactams (including both penicillins and non-
penicillin beta-lactams). Finally, this guidance clarifies that 
manufacturers should generally utilize separate facilities for 
manufacture of non-penicillin beta-lactams because those compounds pose 
health risks associated with cross-reactivity.
    Although the existing current good manufacturing practices (CGMP) 
regulations require separation of manufacturing facilities to avoid 
cross-contamination, the only class of products for which the 
regulations specify particular separation

[[Page 22888]]

requirements are penicillins. This guidance explains that, due to the 
potential health risks of cross-contamination, the Agency expects 
separation for all classes of beta-lactam drugs, including penicillins 
as well as non-penicillin beta-lactams. Specifically, FDA recommends 
that manufacturers establish appropriate separation and control systems 
designed to prevent two types of contamination: (1) The contamination 
of a non-penicillin beta-lactam by any other non-penicillin beta-lactam 
and (2) the contamination of any other type of product by a non-
penicillin beta-lactam. Accordingly, FDA recommends that the area in 
which any class of sensitizing beta-lactam is manufactured should be 
separated from areas in which any other products are manufactured, and 
should have an independent air handling system.
    A draft version of this guidance was published in March 2011 as 
``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This 
final version was revised in response to docket comments to clarify 
that this guidance does not provide a formal risk assessment, but, 
rather, describes FDA's expectations and recommendations for separation 
strategies to prevent cross-contamination.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on Non-Penicillin Beta-Lactam Drugs: A CGMP 
Framework for Preventing Cross-Contamination. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08913 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-01-P
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