82_FR_19127 82 FR 19049 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests

82 FR 19049 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range19049-19050
FR Document2017-08303

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19049-19050]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2066]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Certification of 
Identity for Freedom of Information Act and Privacy Act Requests

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 25, 
2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Certification of Identity for Freedom of Information Act and 
Privacy Act Requests.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Cappezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Certification of Identity for Freedom of Information Act and Privacy 
Act Requests--OMB Control Number 0910--NEW

    In compliance with 44 U.S.C. 3507, FDA will submit to OMB a request 
to review and approve a new collection of information: Certification of 
Identity for Freedom of Information Act and Privacy Act Requests. This 
new form provides the FDA with data necessary to identify an individual 
requesting a particular record under the Freedom of Information Act 
(FOIA) and the Privacy Act. The form is available at the following FDA 
FOIA page at: https://www.fda.gov/RegulatoryInformation/FOI/default.htm, although if an individual requests one, we will send it by 
mail or email. The FOIA grants the public a right to access Federal 
records not normally prepared for public distribution. The Privacy Act 
grants a right of access to members of the public who seek access to 
one's own records that are maintained in an Agency's system of records 
(i.e. the records are retrieved by that individual's name or other 
personal identifier). The statutes overlap, and individuals who request 
their own records are processed under both statutes. The Agency may 
need to confirm that the individual making the FOIA or Privacy Act 
request is indeed the same person named in the Agency records.
    Members of the public who wish to access particular records will be 
asked for certain information: Name, citizenship status, social 
security number, address, date of birth, place of birth, signature, and 
date of signature.
    In the Federal Register of August 4, 2016 (81 FR 51455), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:
    As stated in table 1, the estimates are based on the following: The 
number of FOIA and Privacy Act requests received by FDA each year that 
require a certification of identity in order for FDA to process the 
request. Of the 10,000 requests received per year, only a small number 
require a certification of identity. In some cases, the requesters 
provide their own certification of identity. Therefore, we have 
estimated the number of affected individuals at 60 per year.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                      Number of
                  FDA form No.                       Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
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3975............................................              60                1               60   0.17 (10 minutes).................              10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 19050]]

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08303 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19049 noted, these activities will be conducted ACTION: Notice. record under the Freedom of throughout the United States. Information Act (FOIA) and the Privacy Each notice is available for inspection SUMMARY: The Food and Drug Act. The form is available at the at the Federal Reserve Bank indicated. Administration (FDA) is announcing following FDA FOIA page at: https:// The notice also will be available for that a proposed collection of www.fda.gov/RegulatoryInformation/ inspection at the offices of the Board of information has been submitted to the FOI/default.htm, although if an Governors. Interested persons may Office of Management and Budget individual requests one, we will send it express their views in writing on the (OMB) for review and clearance under by mail or email. The FOIA grants the question whether the proposal complies the Paperwork Reduction Act of 1995. public a right to access Federal records with the standards of section 10(c)(4)(B) DATES: Fax written comments on the not normally prepared for public of the HOLA 12 U.S.C. 1467a(c)(4)(B). collection of information by May 25, distribution. The Privacy Act grants a Unless otherwise noted, comments 2017. right of access to members of the public regarding the notices must be received ADDRESSES: To ensure that comments on who seek access to one’s own records at the Reserve Bank indicated or the that are maintained in an Agency’s the information collection are received, offices of the Board of Governors not system of records (i.e. the records are OMB recommends that written later than May 10, 2017. retrieved by that individual’s name or A. Federal Reserve Bank of Dallas comments be faxed to the Office of Information and Regulatory Affairs, other personal identifier). The statutes (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, OMB, Attn: FDA Desk Officer, FAX: overlap, and individuals who request Dallas, Texas 75201–2272: 202–395–7285, or emailed to oira_ their own records are processed under 1. The SLHC Trust and The Mark and submission@omb.eop.gov. All both statutes. The Agency may need to Pamela Okada Family Trust, and comments should be identified with the confirm that the individual making the NexBank Capital, Inc., all of Dallas, OMB control number 0910–NEW and FOIA or Privacy Act request is indeed Texas; to continue to engage in the title ‘‘Certification of Identity for the same person named in the Agency activities of (i) the acquisition of Freedom of Information Act and Privacy records. improved real estate to be held for rental Act Requests.’’ Also include the FDA Members of the public who wish to and (ii) the maintenance and docket number found in brackets in the access particular records will be asked management of improved real estate heading of this document. for certain information: Name, pursuant to sections 238.53(b)(6) and FOR FURTHER INFORMATION CONTACT: citizenship status, social security (b)(8) of Regulation LL. JonnaLynn Cappezzuto, Office of number, address, date of birth, place of Board of Governors of the Federal Reserve Operations, Food and Drug birth, signature, and date of signature. System, April 19, 2017. Administration, Three White Flint North, 10A63, 11601 Landsdown St., In the Federal Register of August 4, Margaret M. Shanks, 2016 (81 FR 51455), FDA published a North Bethesda, MD 20852, 301–796– Deputy Secretary of the Board. 60-day notice requesting public 3794. [FR Doc. 2017–08276 Filed 4–24–17; 8:45 am] comment on the proposed collection of BILLING CODE 6210–01–P SUPPLEMENTARY INFORMATION: In information. No comments were compliance with 44 U.S.C. 3507, FDA received. has submitted the following proposed FDA estimates the burden of this DEPARTMENT OF HEALTH AND collection of information to OMB for collection of information as follows: HUMAN SERVICES review and clearance. As stated in table 1, the estimates are Certification of Identity for Freedom of based on the following: The number of Food and Drug Administration Information Act and Privacy Act FOIA and Privacy Act requests received [Docket No. FDA–2016–N–2066] Requests—OMB Control Number by FDA each year that require a 0910—NEW certification of identity in order for FDA Agency Information Collection In compliance with 44 U.S.C. 3507, to process the request. Of the 10,000 Activities; Submission for Office of FDA will submit to OMB a request to requests received per year, only a small Management and Budget Review; review and approve a new collection of number require a certification of Comment Request; Certification of information: Certification of Identity for identity. In some cases, the requesters Identity for Freedom of Information Act Freedom of Information Act and Privacy provide their own certification of and Privacy Act Requests Act Requests. This new form provides identity. Therefore, we have estimated AGENCY: Food and Drug Administration, the FDA with data necessary to identify the number of affected individuals at 60 HHS. an individual requesting a particular per year. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual FDA form No. responses per Average burden per response Total hours respondents responses respondent 3975 .................................................. 60 1 60 0.17 (10 minutes) ............................. 10 asabaliauskas on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

19050 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices Dated: April 19, 2017. Guidance for Industry on Citizen collection burden estimates in this Anna K. Abram, Petitions and Petitions for Stay of document. Deputy Commissioner for Policy, Planning, Action Subject to Section 505(q) of the Section 505(q)(1)(H) of the FD&C Act Legislation, and Analysis. Federal Food, Drug, and Cosmetic requires that citizen petitions and [FR Doc. 2017–08303 Filed 4–24–17; 8:45 am] Act—OMB Control Number 0910– petitions for stay of Agency action that 0679—Extension are subject to section 505(q) include a BILLING CODE 4164–01–P certification to be considered for review FDA’s guidance for industry entitled by FDA. Section 505(q)(1)(I) of the ‘‘Citizen Petitions and Petitions for Stay FD&C Act requires that supplemental DEPARTMENT OF HEALTH AND of Action Subject to Section 505(q) of information or comments to such citizen HUMAN SERVICES the Federal Food, Drug, and Cosmetic petitions and petitions for stay of Act’’ provides information regarding Agency action include a verification to Food and Drug Administration FDA’s current thinking on interpreting be accepted for review by FDA. The section 914 of Title IX of the Food and guidance sets forth the criteria the [Docket No. FDA–2009–D–0008] Drug Administration Amendments Act Agency will use in determining if the (FDAAA) (Pub. L. 110–85). Section 914 provisions of section 505(q) of the FD&C Agency Information Collection of FDAAA added new section 505(q) to Act apply to a particular citizen petition Activities; Submission for Office of the Federal Food, Drug, and Cosmetic or petition for stay of Agency action. Management and Budget Review; Act (the FD&C Act) (21 U.S.C. 355(q)) The guidance states that one of the Comment Request; Citizen Petitions and governs certain citizen petitions criteria for a citizen petition or petition and Petitions for Stay of Action and petitions for stay of Agency action for stay of Agency action to be subject Subject to Section 505(q) of the that request that FDA take any form of to section 505(q) of the FD&C Act is that Federal Food, Drug, and Cosmetic Act action related to a pending application a related ANDA or 505(b)(2) application submitted under section 505(b)(2) or is pending at the time the citizen AGENCY: Food and Drug Administration, 505(j) of the FD&C Act. The guidance petition or petition for stay is submitted. HHS. describes FDA’s interpretation of Because petitioners or commenters may section 505(q) of the FD&C Act not be aware of the existence of a ACTION: Notice. regarding how the Agency will pending ANDA or 505(b)(2) application, determine if: (1) The provisions of the guidance recommends that all SUMMARY: The Food and Drug petitioners challenging the Administration (FDA or we) is section 505(q) addressing the treatment of citizen petitions and petitions for stay approvability of a possible ANDA or announcing that a proposed collection 505(b)(2) application include the of Agency action (collectively, petitions) of information has been submitted to the certification required in section apply to a particular petition and (2) a Office of Management and Budget petition would delay approval of a 505(q)(1)(H) of the FD&C Act and that (OMB) for review and clearance under pending abbreviated new drug petitioners and commenters submitting the Paperwork Reduction Act of 1995. application (ANDA) or a 505(b)(2) supplements or comments, respectively, application. The guidance also describes to a citizen petition or petition for stay DATES: Fax written comments on the how FDA will interpret the provisions of action challenging the approvability collection of information by May 25, of section 505(q) requiring that: (1) A of a possible ANDA or 505(b)(2) 2017. application include the verification petition includes a certification and (2) ADDRESSES: To ensure that comments on supplemental information or comments required in section 505(q)(1)(I) of the the information collection are received, to a petition include a verification. FD&C Act. The guidance also OMB recommends that written Finally, the guidance addresses the recommends that if a petitioner submits relationship between the review of a citizen petition or petition for stay of comments be faxed to the Office of petitions and pending ANDAs and Agency action that is missing the Information and Regulatory Affairs, 505(b)(2) applications for which the required certification but is otherwise OMB, Attn: FDA Desk Officer, FAX: within the scope of section 505(q) of the 202–395–7285, or emailed to oira_ Agency has not yet made a decision on approvability. FD&C Act and the petitioner would like submission@omb.eop.gov. All FDA to review the citizen petition or comments should be identified with the The Food and Drug Administration petition for stay of Agency action, the OMB control number 0910–0679. Also Safety and Innovation Act (FDASIA) petitioner should submit a letter include the FDA docket number found was signed into law on July 9, 2012 withdrawing the deficient petition and in brackets in the heading of this (Pub. L. 112–144). Section 1135 of submit a new petition that contains the document. FDASIA amended section 505(q) of the required certification. FD&C Act in two ways. First, it FDA currently has OMB approval for FOR FURTHER INFORMATION CONTACT: shortened FDA’s deadline from 180 the collection of information entitled JonnaLynn Capezzuto, Office of days to 150 days for responding to ‘‘General Administrative Procedures: Operations, Food and Drug petitions subject to section 505(q) of the Citizen Petitions; Petition for Administration, Three White Flint FD&C Act. Second, it expanded the Reconsideration or Stay of Action; North, 10A63, 11601 Landsdown St., scope of section 505(q) of the FD&C Act Advisory Opinions’’ (OMB control North Bethesda, MD 20852, 301–796– to include certain petitions concerning number 0910–0191). This collection of asabaliauskas on DSK3SPTVN1PROD with NOTICES 3794. applications submitted under section information includes, among other 351(k) of the Public Health Service Act things: (1) The format and procedures SUPPLEMENTARY INFORMATION: In (42 U.S.C. 262), the abbreviated by which an interested person may compliance with 44 U.S.C. 3507, FDA pathway for the approval of biosimilar submit to FDA, in accordance with has submitted the following proposed biological products. Accordingly, we are § 10.20 (21 CFR 10.20), a citizen petition collection of information to OMB for now including submissions pertaining requesting the Commissioner of Food review and clearance. to biosimilar biological product and Drugs (Commissioner) to issue, applications in the information amend, or revoke a regulation or order, VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:52
Document Modified: 2017-04-25 02:18:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by May 25, 2017.
ContactJonnaLynn Cappezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation82 FR 19049 
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