80 FR 76699 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 237 (December 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76699-76701 | |
| FR Document | 2015-31100 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Pages 76699-76701] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 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 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 http://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
![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76699
II. Determination of Regulatory Review investigation. (See H. Rept. 857, part 1, Program is part of the FDA performance
Period 98th Cong., 2d sess., pp. 41–42, 1984.) commitments under the fifth
FDA has determined that the Petitions should be in the format authorization of the Prescription Drug
applicable regulatory review period for specified in 21 CFR 10.30. User Fee Act (PDUFA), which allows
ARGUS II VISUAL STIMULATION Submit petitions electronically to FDA to collect user fees for the review
SYSTEM is 2,282 days. Of this time, http://www.regulations.gov at Docket of human drug and biologics
1,630 days occurred during the testing No. FDA–2013–S–0610. Submit written applications for FYs 2013–2017.
phase of the regulatory review period, petitions (two copies are required) to the DATES: Submit either electronic or
while 652 days occurred during the Division of Dockets Management (HFA– written comments on the collection of
approval phase. These periods of time 305), Food and Drug Administration, information by February 8, 2016.
were derived from the following dates: 5630 Fishers Lane, Rm. 1061, Rockville, ADDRESSES: You may submit comments
1. The date an exemption under MD 20852. Petitions that have not been as follows:
section 520(g) of the Federal Food, Drug, made publicly available on http://
www.regulations.gov may be viewed in Electronic Submissions
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device the Division of Dockets Management Submit electronic comments in the
became effective: November 17, 2006. between 9 a.m. and 4 p.m., Monday following way:
The applicant claims that the through Friday. • Federal eRulemaking Portal: http://
investigational device exemption (IDE) Dated: December 4, 2015. www.regulations.gov. Follow the
required under section 520(g) of the Leslie Kux, instructions for submitting comments.
FD&C act for human tests to begin Associate Commissioner for Policy. Comments submitted electronically,
became effective on December 31, 2004. [FR Doc. 2015–31095 Filed 12–9–15; 8:45 am] including attachments, to http://
However, FDA records indicate that the BILLING CODE 4164–01–P
www.regulations.gov will be posted to
IDE was determined substantially the docket unchanged. Because your
complete for clinical studies to have comment will be made public, you are
begun on November 17, 2006, which DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
represents the IDE effective date. HUMAN SERVICES comment does not include any
2. The date an application was confidential information that you or a
initially submitted with respect to the Food and Drug Administration third party may not wish to be posted,
device under section 515 of the FD&C such as medical information, your or
[Docket No. FDA–2013–N–0093]
Act (21 U.S.C. 360e): May 4, 2011. The anyone else’s Social Security number, or
applicant claims May 3, 2011, as the Agency Information Collection confidential business information, such
date the humanitarian device exemption Activities: Proposed Collection; as a manufacturing process. Please note
(HDE) for Argus II Visual Stimulation Comment Request; Evaluation of the that if you include your name, contact
System (HDE H110002) was initially Program for Enhanced Review information, or other information that
submitted. However, FDA records Transparency and Communication for identifies you in the body of your
indicate that HDE H110002 was New Molecular Entity New Drug comments, that information will be
submitted on May 4, 2011. Applications and Original Biologics posted on http://www.regulations.gov.
3. The date the application was License Applications in Prescription • If you want to submit a comment
approved: February 13, 2013. The Drug User Fee Acts with confidential information that you
applicant claims that HDE H110002 was do not wish to be made available to the
approved on February 14, 2013. AGENCY: Food and Drug Administration, public, submit the comment as a
However, FDA records indicate that HHS. written/paper submission and in the
ARGUS II VISUAL STIMULATION ACTION: Notice. manner detailed (see ‘‘Written/Paper
SYSTEM was approved on February 13, Submissions’’ and ‘‘Instructions’’).
2013. SUMMARY: The Food and Drug
Administration (FDA) is announcing an Written/Paper Submissions
This determination of the regulatory
review period establishes the maximum opportunity for public comment on the Submit written/paper submissions as
potential length of a patent extension. proposed collection of certain follows:
However, the USPTO applies several information by the Agency. Under the • Mail/Hand delivery/Courier (for
statutory limitations in its calculations Paperwork Reduction Act of 1995 (the written/paper submissions): Division of
of the actual period for patent extension. PRA), Federal Agencies are required to Dockets Management (HFA–305), Food
In its application for patent extension, publish notice in the Federal Register and Drug Administration, 5630 Fishers
this applicant seeks 1,735 days of patent concerning each proposed collection of Lane, Rm. 1061, Rockville, MD 20852.
term extension. information, including each proposed • For written/paper comments
extension of an existing collection of submitted to the Division of Dockets
III. Petitions information, and to allow 60 days for Management, FDA will post your
Anyone with knowledge that any of public comment in response to the comment, as well as any attachments,
the dates as published are incorrect may notice. This notice solicits comments on except for information submitted,
submit either electronic or written the information collection involving marked and identified, as confidential,
comments and ask for a redetermination interviews of pharmaceutical if submitted as detailed in
mstockstill on DSK4VPTVN1PROD with NOTICES
(see DATES). Furthermore, any manufacturers who submit new ‘‘Instructions.’’
interested person may petition FDA for molecular entity (NME) new drug Instructions: All submissions received
a determination regarding whether the applications (NDAs) and original must include the Docket No. [FDA–
applicant for extension acted with due biologics license applications (BLAs) to 2013–N–0093] for ‘‘Agency Information
diligence during the regulatory review FDA under the Program for Enhanced Collection Activities: Proposed
period. To meet its burden, the petition Review Transparency and Collection; Comment Request;
must be timely (see DATES) and contain Communication (the Program) during Evaluation of the Program for Enhanced
sufficient facts to merit an FDA fiscal years (FYs) 2013–2017. The Review Transparency and
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![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76701
Thus, FDA estimates the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Portion of study responses per burden per Total hours
respondents responses
respondent 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. • Federal eRulemaking Portal: http:// http://www.regulations.gov or at the
Leslie Kux, www.regulations.gov. Follow the Division of Dockets Management
Associate Commissioner for Policy. instructions for submitting comments. between 9 a.m. and 4 p.m., Monday
[FR Doc. 2015–31100 Filed 12–9–15; 8:45 am] Comments submitted electronically, through Friday.
BILLING CODE 4164–01–P
including attachments, to http:// • Confidential Submissions—To
www.regulations.gov will be posted to submit a comment with confidential
the docket unchanged. Because your
information that you do not wish to be
DEPARTMENT OF HEALTH AND comment will be made public, you are
made publicly available, submit your
HUMAN SERVICES solely responsible for ensuring that your
comments only as a written/paper
comment does not include any
confidential information that you or a submission. You should submit two
Food and Drug Administration
third party may not wish to be posted, copies total. One copy will include the
[Docket No. FDA–2013–E–1573] such as medical information, your or information you claim to be confidential
anyone else’s Social Security number, or with a heading or cover note that states
Determination of Regulatory Review confidential business information, such ‘‘THIS DOCUMENT CONTAINS
Period for Purposes of Patent as a manufacturing process. Please note CONFIDENTIAL INFORMATION’’. The
Extension; VERAFLOX that if you include your name, contact Agency will review this copy, including
information, or other information that the claimed confidential information, in
AGENCY: Food and Drug Administration,
identifies you in the body of your its consideration of comments. The
HHS.
comments, that information will be second copy, which will have the
ACTION: Notice. claimed confidential information
posted on http://www.regulations.gov.
SUMMARY: The Food and Drug • If you want to submit a comment redacted/blacked out, will be available
Administration (FDA) has determined with confidential information that you for public viewing and posted on
the regulatory review period for do not wish to be made available to the http://www.regulations.gov. Submit
VERAFLOX and is publishing this public, submit the comment as a both copies to the Division of Dockets
notice of that determination as required written/paper submission and in the Management. If you do not wish your
by law. FDA has made the manner detailed (see ‘‘Written/Paper name and contact information to be
determination because of the Submissions’’ and ‘‘Instructions’’). made publicly available, you can
submission of an application to the provide this information on the cover
Written/Paper Submissions
Director of U.S. Patent and Trademark sheet and not in the body of your
Submit written/paper submissions as comments and you must identify this
Office (USPTO), Department of
follows: information as ‘‘confidential.’’ Any
Commerce, for the extension of a patent
• Mail/Hand delivery/Courier (for information marked as ‘‘confidential’’
which claims that animal drug product.
written/paper submissions): Division of will not be disclosed except in
DATES: Anyone with knowledge that any Dockets Management (HFA–305), Food
of the dates as published (in the accordance with 21 CFR 10.20 and other
and Drug Administration, 5630 Fishers applicable disclosure law. For more
SUPPLEMENTARY INFORMATION section) are Lane, Rm. 1061, Rockville, MD 20852. information about FDA’s posting of
incorrect may submit either electronic • For written/paper comments
or written comments and ask for a comments to public dockets, see 80 FR
submitted to the Division of Dockets
redetermination by February 8, 2016. 56469, September 18, 2015, or access
Management, FDA will post your
Furthermore, any interested person may the information at: http://www.fda.gov/
comment, as well as any attachments,
petition FDA for a determination regulatoryinformation/dockets/
except for information submitted,
regarding whether the applicant for default.htm.
marked and identified, as confidential,
extension acted with due diligence if submitted as detailed in Docket: For access to the docket to
during the regulatory review period by ‘‘Instructions’’. read background documents or the
June 7, 2016. See ‘‘Petitions’’ in the Instructions: All submissions received electronic and written/paper comments
SUPPLEMENTARY INFORMATION section for received, go to http://
mstockstill on DSK4VPTVN1PROD with NOTICES
must include the Docket No. FDA–
more information. 2013–E–1573 for ‘‘Determination of www.regulations.gov and insert the
ADDRESSES: You may submit comments Regulatory Review Period for Purposes docket number, found in brackets in the
as follows: of Patent Extension; VERAFLOX’’. heading of this document, into the
Received comments will be placed in ‘‘Search’’ box and follow the prompts
Electronic Submissions the docket and, except for those and/or go to the Division of Dockets
Submit electronic comments in the submitted as ‘‘Confidential Management, 5630 Fishers Lane, Rm.
following way: Submissions,’’ publicly viewable at 1061, Rockville, MD 20852.
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Document Created: 2015-12-14 13:28:38
Document Modified: 2015-12-14 13:28:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by February 8, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 76699 |
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