Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability, 81774-81776 [2016-27761]

Download as PDF 81774 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices device exemption (HDE), petition for Evaluation of Automatic Class III Designation (de novo), or be reclassified into class I or class II before being marketed. FDA makes the final decision of whether a device is substantially equivalent or not equivalent. Section 807.81 states when a premarket notification is required. A premarket notification is required to be submitted by a person who is: (1) Introducing a device to the market for the first time; (2) introducing a device into commercial distribution for the first time by a person who is required to register; and (3) introducing or reintroducing a device which is significantly changed or modified in design, components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the device. Form FDA 3514, a summary cover sheet form, assists respondents in categorizing administrative 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and HDEs. Under § 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) as required by § 807.92 (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) with certain exceptions as per § 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the 510(k) submission, § 807.93 requires that the official correspondent of the firm make available within 30 days of a request all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any person within 30 days of a request if the device described in the 510(k) submission is determined to be substantially equivalent. The information provided will be a duplicate of the 510(k) submission including any safety and effectiveness information, but excluding all patient identifiers and trade secret and commercial confidential information. Section 204 of the Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105–115) amended section 514 of the FD&C Act (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. Form FDA 3654, the 510(k) Standards Data Form, standardizes the format for submitting information on consensus standards that a 510(k) submitter chooses to use as a portion of their premarket notification submission (Form FDA 3654 is not for declarations of conformance to a recognized standard). FDA believes that use of this form will simplify the 510(k) preparation and review process for 510(k). Under § 807.90, submitters may request information on their 510(k) review status 90 days after the initial login date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, Form FDA 3541, and fax it to the Center for Devices and Radiological Health office identified on the form. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of respondents Number of responses per respondent Average burden per response Total annual responses Total hours Activity and 21 CFR Part/Section Form No. 510(k) submission (807 subpart E). Summary cover sheet (807.87) ... Status request (807.90(a)(3)) ...... Standards (807.87(d) and (f)) ...... 510(k) statement (807.93) ........... ........................ 3,900 1 3,900 79 .............................. 308,100 FDA 3514 ...... FDA 3541 ...... FDA 3654 ...... ........................ 1,956 218 2,700 225 1 1 1 10 1,956 218 2,700 2,250 0.5 (30 minutes) ........ 0.25 (15 minutes) ...... 10 .............................. 10 .............................. 978 55 27,000 22,500 Total ...................................... ........................ ........................ ........................ ........................ .................................... 358,633 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27851 Filed 11–17–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0880] BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled ‘‘Generic Drug User SUMMARY: VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.’’ This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance. Submit either electronic or written comments on Agency guidances at any time. DATES: ADDRESSES: You may submit comments as follows: E:\FR\FM\18NON1.SGM 18NON1 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 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’’). mstockstill on DSK3G9T082PROD with NOTICES 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– 2012–D–0880 for ‘‘Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.’’ 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 VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 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. 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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. FOR FURTHER INFORMATION CONTACT: Mehrban Iranshad, Division of User Fee Management and Budget Formulation staff, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 4145, Silver Spring, MD 20993, 301–796–7900, AskGDUFA@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Generic Drug User Fee Amendments of PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 81775 2012: Questions and Answers Related to User Fee Assessments.’’ GDUFA (Pub. L. 112–144, Title III) was signed into law by the President on July 9, 2012. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA’s generic drugs program. GDUFA establishes fees for abbreviated new drug applications (ANDAs), prior approval supplements (PASs) to ANDAs, and drug master files (DMFs), annual facility fees, and a onetime fee for original ANDAs pending with FDA on October 1, 2012 (backlog fees). Fees are incurred for ANDAs and PASs submitted on or after October 1, 2012. An application fee is also incurred the first time a DMF is referenced in an ANDA or PAS submitted on or after October 1, 2012. FDA previously announced GDUFA fees for fiscal year 2017 in the Federal Register. ANDA, PAS, DMF, and facility fees were published on July 27, 2016 (81 FR 49225), and the backlog fee was published on October 25, 2012 (77 FR 65199). On August 27, 2012, FDA announced the availability of a draft guidance for industry entitled ‘‘Generic Drug User Fee Amendments of 2012: Questions and Answers’’ (77 FR 51814). In response to comments received in the docket and to address additional questions that have arisen since the launch of the GDUFA program, FDA revised the draft guidance and re-issued it as ‘‘Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)’’ on September 10, 2013 (78 FR 55261). The guidance announced in this notice finalizes the section of Revision 1 relating to user fees, updating and clarifying the responses in some cases and adding questions and answers based on comments received from the public. Questions and answers related to GDUFA’s self-identification, review of generic drug submissions, and inspections and compliance provisions that appeared in draft versions of this guidance will appear in updated form in a separately issued final guidance. 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 ‘‘Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the E:\FR\FM\18NON1.SGM 18NON1 81776 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27761 Filed 11–17–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: [Docket No. FDA–2016–N–3535] • Mail/Hand delivery/Courier (for written/paper submissions): Division of Agency Information Collection Dockets Management (HFA–305), Food Activities: Proposed Collection; and Drug Administration, 5630 Fishers Comment Request; Guidance for Lane, Rm. 1061, Rockville, MD 20852. Industry on Special Protocol • For written/paper comments Assessment submitted to the Division of Dockets AGENCY: Food and Drug Administration, Management, FDA will post your HHS. comment, as well as any attachments, ACTION: Notice. except for information submitted, marked and identified, as confidential, SUMMARY: The Food and Drug if submitted as detailed in Administration (FDA) is announcing an ‘‘Instructions.’’ opportunity for public comment on the Instructions: All submissions received proposed collection of certain must include the Docket No. FDA– information by the Agency. Under the 2016–N–3535 for ‘‘Agency Information Paperwork Reduction Act of 1995 (the Collection Activities: Proposed PRA), Federal Agencies are required to Collection; Comment Request; Guidance publish notice in the Federal Register for Industry on Special Protocol concerning each proposed collection of Assessment.’’ Received comments will information, including each proposed be placed in the docket and, except for extension of an existing collection of those submitted as ‘‘Confidential information, and to allow 60 days for Submissions,’’ publicly viewable at public comment in response to the https://www.regulations.gov or at the notice. This notice solicits comments on Division of Dockets Management the information collection in the between 9 a.m. and 4 p.m., Monday guidance for industry on special through Friday. protocol assessment. • Confidential Submissions—To DATES: Submit either electronic or submit a comment with confidential written comments on the collection of information that you do not wish to be information by January 17, 2017. made publicly available, submit your comments only as a written/paper ADDRESSES: You may submit comments submission. You should submit two as follows: copies total. One copy will include the Electronic Submissions information you claim to be confidential with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: • Federal eRulemaking Portal: https:// CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including www.regulations.gov. Follow the the claimed confidential information, in instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the including attachments, to https:// claimed confidential information www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on comment will be made public, you are solely responsible for ensuring that your https://www.regulations.gov. Submit mstockstill on DSK3G9T082PROD with NOTICES Food and Drug Administration VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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, Three White Flint North, 11601 Landsdown St., 10A– 12M, North Bethesda, MD 20852, 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 E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81774-81776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27761]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]

Generic Drug User Fee Amendments of 2012: Questions and Answers
Related to User Fee Assessments; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of guidance for industry entitled ``Generic Drug User
Fee Amendments of 2012: Questions and Answers Related to User Fee
Assessments.'' This guidance provides updated answers to common
questions from the generic drug industry and other interested parties
involved in the development and/or testing of generic drug products
regarding GDUFA user fees and finalizes the revised version of the
guidance.

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

ADDRESSES: You may submit comments as follows:

[[Page 81775]]

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-2012-D-0880 for ``Generic Drug User Fee Amendments of 2012:
Questions and Answers Related to User Fee Assessments.'' 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.
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, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Mehrban Iranshad, Division of User Fee
Management and Budget Formulation staff, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., Rm. 4145, Silver Spring, MD 20993, 301-796-7900,
AskGDUFA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Generic Drug User Fee Amendments of 2012: Questions and
Answers Related to User Fee Assessments.'' GDUFA (Pub. L. 112-144,
Title III) was signed into law by the President on July 9, 2012. GDUFA
is designed to speed the delivery of safe and effective generic drugs
to the public and improve upon the predictability of the review
process. GDUFA enables FDA to assess user fees to support critical and
measurable enhancements to FDA's generic drugs program. GDUFA
establishes fees for abbreviated new drug applications (ANDAs), prior
approval supplements (PASs) to ANDAs, and drug master files (DMFs),
annual facility fees, and a one-time fee for original ANDAs pending
with FDA on October 1, 2012 (backlog fees). Fees are incurred for ANDAs
and PASs submitted on or after October 1, 2012. An application fee is
also incurred the first time a DMF is referenced in an ANDA or PAS
submitted on or after October 1, 2012.
FDA previously announced GDUFA fees for fiscal year 2017 in the
Federal Register. ANDA, PAS, DMF, and facility fees were published on
July 27, 2016 (81 FR 49225), and the backlog fee was published on
October 25, 2012 (77 FR 65199). On August 27, 2012, FDA announced the
availability of a draft guidance for industry entitled ``Generic Drug
User Fee Amendments of 2012: Questions and Answers'' (77 FR 51814). In
response to comments received in the docket and to address additional
questions that have arisen since the launch of the GDUFA program, FDA
revised the draft guidance and re-issued it as ``Draft Guidance for
Industry on Generic Drug User Fee Amendments of 2012: Questions and
Answers (Revision 1)'' on September 10, 2013 (78 FR 55261). The
guidance announced in this notice finalizes the section of Revision 1
relating to user fees, updating and clarifying the responses in some
cases and adding questions and answers based on comments received from
the public. Questions and answers related to GDUFA's self-
identification, review of generic drug submissions, and inspections and
compliance provisions that appeared in draft versions of this guidance
will appear in updated form in a separately issued final guidance.
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 ``Generic Drug User Fee Amendments of
2012: Questions and Answers Related to User Fee Assessments.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the

[[Page 81776]]

requirements of the applicable statutes and regulations.

II. Electronic Access

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

Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27761 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P

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