Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act, 11652-11654 [2013-03705]

Download as PDF 11652 Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices 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 ‘‘Manufactured Food Regulatory Program Standards.’’ DATES: Submit either electronic or written comments on the collection of information by April 22, 2013. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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., P150– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@fda.hhs.gov. 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. Manufactured Food Regulatory Program Standards—(OMB Control Number 0910–0601)—Extension In the Federal Register of July 20, 2006 (71 FR 41221), FDA announced the availability of a draft document entitled ‘‘Manufactured Food Regulatory Program Standards (MFRPS).’’ These draft program standards are the framework that States should use to design and manage its manufactured food program. The implementation of the standards will be negotiated as an option for payment under the State food contract. States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards. Additionally, 26 States may receive up to $300,000 each year for a period of 5 years to be in compliance with the 10 standards. In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if they meet the elements of each standard. The State program should use the worksheets and forms contained herein; however, it can use alternate forms that are equivalent. The State program maintains the documents and verifying records required for each standard. The information contained in the documents must be current and fitfor-use. If the State program fails to meet all program elements and documentation requirements of a standard, it develops a strategic plan which includes the following: (1) The individual element of documentation requirement of the standard that was not met; (2) improvements need to meet the program element or documentation requirement of the standard; and (3) projected completion dates for each task. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Respondent Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours State Departments of Agriculture or Health ........................ 44 1 44 303 13,332 TKELLEY on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden has been calculated to 303 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 10 standards contained in MFRPS. The hours per respondent will remain the same as implementation to account for continuing improvement and selfsufficiency in the program. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0093] Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act [FR Doc. 2013–03707 Filed 2–15–13; 8:45 am] AGENCY: BILLING CODE 4160–01–P HHS. VerDate Mar<15>2010 17:49 Feb 15, 2013 Jkt 229001 PO 00000 Food and Drug Administration, Frm 00031 Fmt 4703 Sfmt 4703 ACTION: Notice. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug SUMMARY: E:\FR\FM\19FEN1.SGM 19FEN1 11653 Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (‘‘the Program’’) during fiscal years (FYs) 2013–2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013–2017. DATES: Submit either electronic or written comments on the collection of information by April 22, 2013. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: 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 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. Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in PDUFA V: Interviews of Applicants in the Program (OMB Control Number 0910–New) As part of its commitments in PDUFA V, FDA has established a new review Program to promote greater transparency and increased communication between the FDA review team and the applicant on the most innovative products reviewed by the Agency. The Program applies to all NME NDAs and original BLAs that are received from October 1, 2012, through September 30, 2017. The Program is described in detail in section II.B of the document entitled ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017’’ (the ‘‘Commitment Letter’’) (available at http://www.fda.gov/ downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM270412.pdf. The goals of the Program are to increase the efficiency and effectiveness of the first review cycle and decrease the number of review cycles necessary for approval so that patients have timely access to safe, effective, and highquality new drugs and biologics. A key aspect of the Program is an interim and final assessment that will evaluate how well the parameters of the Program have achieved the intended goals. The PDUFA V Commitment Letter specifies that the assessments be conducted by an independent contractor and that they include interviews of pharmaceutical manufacturers who submit NME NDAs and original BLAs to the Program in PDUFA V. The contractor for the assessments of the Program is Eastern Research Group, Inc. (ERG), and the statement of work for the assessments is available at http://www.fda.gov/ downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM304793.pdf. Therefore, in accordance with the PDUFA V Commitment Letter, FDA proposes to have ERG conduct independent interviews of applicants after FDA issues a first-cycle action for applications reviewed under the Program. The purpose of these interviews is to collect feedback from applicants on the success of the Program in increasing review transparency and communication during the review process. ERG will anonymize and aggregate sponsor responses prior to inclusion in the assessments and any presentation materials at public meetings. FDA will publish ERG’s assessments (with interview results and findings) in the Federal Register for public comment. FDA typically reviews approximately 40 to 45 NME NDAs and original BLAs per year. ERG will interview 1 to 3 sponsor representatives at a time for each application that receives a firstcycle action from FDA—up to 135 sponsor representatives per year. Thus, FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents TKELLEY on DSK3SPTVN1PROD with NOTICES Portion of study Number of responses per respondent Total annual responses Average burden per response Total hours Pretest .................................................................................. Interviews ............................................................................. 5 135 1 1 5 135 1.5 1.5 7.50 202.50 Total .............................................................................. ........................ ........................ ........................ ........................ 210 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ERG will conduct a pretest of the interview protocol with five VerDate Mar<15>2010 17:49 Feb 15, 2013 Jkt 229001 respondents. FDA estimates that it will take 1.0 to 1.5 hours to complete the PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 pretest, for a total of a maximum of 7.5 hours. We estimate that up to 135 E:\FR\FM\19FEN1.SGM 19FEN1 11654 Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices respondents will take part in the postaction interviews each year, with each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total estimated annual burden is 210 hours. FDA’s burden estimate is based on prior experience with similar interviews with the regulated community. Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03705 Filed 2–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0117] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.’’ FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 22, 2013, (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:49 Feb 15, 2013 Jkt 229001 Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to http:// 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: With regard to the guidance: Sheila Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993–0002, 301– 796–6563; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. With regard to the proposed collection of information: 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. I. Background On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) 1 (Pub. L. 110–85) amended the FD&C Act by adding, among other things, a new section 515A (21 U.S.C. 360e–1) of the FD&C Act. Section 515A(a) of the FD&C Act requires persons who submit certain medical device applications to include, if readily available: 1. A description of any pediatric subpopulations that suffer from the 1 Title III of FDAAA, which includes new section 515A, is also known as the Pediatric Medical Device Safety and Improvement Act of 2007. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 disease or condition that the device is intended to treat, diagnose, or cure; and 2. The number of affected pediatric patients. The purpose of this guidance document is to describe the type of information that FDA believes is readily available to the applicant, and the information FDA believes should be included in a submission to meet the requirements of section 515A(a) of the FD&C Act. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1801 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 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 that they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320(c) and includes Agency requests or requirements that members of the public E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11652-11654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03705]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of the Program for Enhanced Review 
Transparency and Communication for New Molecular Entity New Drug 
Applications and Original Biologics License Applications in 
Prescription Drug User Fee Act

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a proposed information collection involving 
interviews of pharmaceutical manufacturers who submit new molecular 
entity (NME) new drug

[[Page 11653]]

applications (NDAs) and original biologics license applications (BLAs) 
to FDA under the Program for Enhanced Review Transparency and 
Communication (``the Program'') during fiscal years (FYs) 2013-2017. 
The Program is part of the FDA performance commitments under the fifth 
authorization of the Prescription Drug User Fee Act (PDUFA), which 
allows FDA to collect user fees for the review of human drug and 
biologics applications for FYs 2013-2017.

DATES: Submit either electronic or written comments on the collection 
of information by April 22, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. All comments should be identified with the 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: 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 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.

Evaluation of the Program for Enhanced Review Transparency and 
Communication for New Molecular Entity New Drug Applications and 
Original Biologics License Applications in PDUFA V: Interviews of 
Applicants in the Program (OMB Control Number 0910-New)

    As part of its commitments in PDUFA V, FDA has established a new 
review Program to promote greater transparency and increased 
communication between the FDA review team and the applicant on the most 
innovative products reviewed by the Agency. The Program applies to all 
NME NDAs and original BLAs that are received from October 1, 2012, 
through September 30, 2017. The Program is described in detail in 
section II.B of the document entitled ``PDUFA Reauthorization 
Performance Goals and Procedures Fiscal Years 2013 through 2017'' (the 
``Commitment Letter'') (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    The goals of the Program are to increase the efficiency and 
effectiveness of the first review cycle and decrease the number of 
review cycles necessary for approval so that patients have timely 
access to safe, effective, and high-quality new drugs and biologics. A 
key aspect of the Program is an interim and final assessment that will 
evaluate how well the parameters of the Program have achieved the 
intended goals. The PDUFA V Commitment Letter specifies that the 
assessments be conducted by an independent contractor and that they 
include interviews of pharmaceutical manufacturers who submit NME NDAs 
and original BLAs to the Program in PDUFA V. The contractor for the 
assessments of the Program is Eastern Research Group, Inc. (ERG), and 
the statement of work for the assessments is available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
    Therefore, in accordance with the PDUFA V Commitment Letter, FDA 
proposes to have ERG conduct independent interviews of applicants after 
FDA issues a first-cycle action for applications reviewed under the 
Program. The purpose of these interviews is to collect feedback from 
applicants on the success of the Program in increasing review 
transparency and communication during the review process. ERG will 
anonymize and aggregate sponsor responses prior to inclusion in the 
assessments and any presentation materials at public meetings. FDA will 
publish ERG's assessments (with interview results and findings) in the 
Federal Register for public comment.
    FDA typically reviews approximately 40 to 45 NME NDAs and original 
BLAs per year. ERG will interview 1 to 3 sponsor representatives at a 
time for each application that receives a first-cycle action from FDA--
up to 135 sponsor representatives per year. Thus, FDA estimates the 
burden of this collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        Portion of study             Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
Pretest.........................               5               1               5             1.5            7.50
Interviews......................             135               1             135             1.5          202.50
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    ERG will conduct a pretest of the interview protocol with five 
respondents. FDA estimates that it will take 1.0 to 1.5 hours to 
complete the pretest, for a total of a maximum of 7.5 hours. We 
estimate that up to 135

[[Page 11654]]

respondents will take part in the post-action interviews each year, 
with each interview lasting 1.0 to 1.5 hours, for a total of a maximum 
of 202.5 hours. Thus, the total estimated annual burden is 210 hours. 
FDA's burden estimate is based on prior experience with similar 
interviews with the regulated community.

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03705 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P