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 Acts, 76699-76701 [2015-31100]

Download as PDF Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM is 2,282 days. Of this time, 1,630 days occurred during the testing phase of the regulatory review period, while 652 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: November 17, 2006. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C act for human tests to begin became effective on December 31, 2004. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on November 17, 2006, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): May 4, 2011. The applicant claims May 3, 2011, as the date the humanitarian device exemption (HDE) for Argus II Visual Stimulation System (HDE H110002) was initially submitted. However, FDA records indicate that HDE H110002 was submitted on May 4, 2011. 3. The date the application was approved: February 13, 2013. The applicant claims that HDE H110002 was approved on February 14, 2013. However, FDA records indicate that ARGUS II VISUAL STIMULATION SYSTEM was approved on February 13, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,735 days of patent term extension. mstockstill on DSK4VPTVN1PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on https:// www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–31095 Filed 12–9–15; 8:45 am] BILLING CODE 4164–01–P 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 Acts AGENCY: Food and Drug Administration, HHS. 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, 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 information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug 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 SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 76699 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 February 8, 2016. ADDRESSES: You may submit comments as follows: 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 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): 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– 2013–N–0093] for ‘‘Agency Information Collection Activities: Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and E:\FR\FM\10DEN1.SGM 10DEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 76700 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 https:// 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: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 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, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA, 44 U.S.C. 3501–3520, Federal VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 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. 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 Acts (OMB Control Number 0910–0746)— Extension As part of its commitments in PDUFA V, FDA 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 NMEs, 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 https://www.fda.gov/ PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 NMEs, 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 https://www.fda.gov/ downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM304793.pdf. In accordance with the PDUFA V Commitment Letter, FDA contracted with ERG to 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 NMEs, NDAs, and original BLAs per year. ERG interviews 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. ERG conducts 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 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. E:\FR\FM\10DEN1.SGM 10DEN1 76701 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices Thus, FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Portion of study Number of responses per respondent Total annual responses Average burden per response Total hours Pre-test ................................................................................. 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. Dated: December 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–31100 Filed 12–9–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–E–1573] Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for VERAFLOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 8, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 7, 2016. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 • 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 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): 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– 2013–E–1573 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX’’. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 https://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 https://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: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76699-76701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31100]


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

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 Acts

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 information collection 
involving interviews of pharmaceutical manufacturers who submit new 
molecular entity (NME) new drug 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 February 8, 2016.

ADDRESSES: You may submit comments as follows:

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 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): 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-2013-N-0093] for ``Agency Information Collection Activities: 
Proposed Collection; Comment Request; Evaluation of the Program for 
Enhanced Review Transparency and

[[Page 76700]]

Communication for New Molecular Entity New Drug Applications and 
Original Biologics License Applications in Prescription Drug User Fee 
Acts.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://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 https://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: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 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, PRAStaff@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.

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 
Acts

(OMB Control Number 0910-0746)--Extension

    As part of its commitments in PDUFA V, FDA 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 NMEs, 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 https://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 NMEs, 
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 https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.
    In accordance with the PDUFA V Commitment Letter, FDA contracted 
with ERG to 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 NMEs, NDAs, and 
original BLAs per year. ERG interviews 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. ERG conducts 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 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.

[[Page 76701]]

    Thus, FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        Portion of study             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pre-test........................               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.


    Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31100 Filed 12-9-15; 8:45 am]
 BILLING CODE 4164-01-P
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