81 FR 51455 - Agency Information Collection Activities; Proposed Collection; 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 81, Issue 150 (August 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 150 (August 4, 2016)
| Page Range | 51455-51456 | |
| FR Document | 2016-18463 |
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)] [Notices] [Pages 51455-51456] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18463] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2066] Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Certification of Identity for Freedom of Information Act and Privacy Act Requests.'' DATES: Submit either electronic or written comments on the collection of information by October 3, 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-2016-N-2066 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests.'' 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 [[Page 51456]] 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 the Office of Management and Budget 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: http://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. 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of FDA Form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 3975....................................... 60 1 60 .17 (10 minutes)....................... 10 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18463 Filed 8-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices 51455
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2016, THROUGH JUNE 30, 2016—Continued
PMA No., Docket No. Applicant Trade name Approval date
P150033, FDA–2016–M–1125 ................ Medtronic, Inc .......................................... Medtronic MicraTM Transcatheter Pace- 4/6/2016
maker System.
P140003/S005, FDA–2016–M–1165 ....... Abiomed, Inc ........................................... Impella Left Ventricular Support System 4/7/2016
P150041, FDA–2016–M–1167 ................ Abbott Molecular, Inc .............................. Vysis CLL FISH Probe Kit ....................... 4/11/2016
P150016, FDA–2016–M–1166 ................ Neomend, Inc .......................................... TRIDYNETM Vascular Sealant ................ 4/11/2016
P130001, FDA–2016–M–1168 ................ Epigenomics AG ...................................... Epi proColon ............................................ 4/12/2016
P150012, FDA–2016–M–1222 ................ Boston Scientific Corporation .................. ImageReady MR Conditional Pacing 4/25/2016
System and Ingevity Pace/Sense Lead.
P130029/S002, FDA–2016–M–1223 ....... Bard Peripheral Vascular, Inc ................. Fluency® Plus Endovascular Stent Graft 4/26/2016
P160002, FDA–2016–M–1400 ................ Ventana Medical Systems, Inc ................ VENTANA PD–L1(SP142) Assay ........... 5/18/2016
P070014/S037, FDA–2016–M–1455 ....... Bard Peripheral Vascular, Inc ................. Bard® LifeStent Vascular Stent System 5/31/2016
P110033/S018, FDA–2016–M–1401 ....... Allergan ................................................... JUVÉDERM VOLBELLA® XC ................. 5/31/2016
P150047, FDA–2016–M–1459 ................ Roche Molecular Systems, Inc ............... cobas® EGFR Mutation Test v2 ............. 6/1/2016
P150024, FDA–2016–M–1754 ................ Aspire Bariatrics, Inc ............................... AspireAssist® ........................................... 6/14/2016
P150029, FDA–2016–M–1755 ................ Medtronic Minimed, Inc ........................... iPro2 Continuous Glucose Monitoring 6/17/2016
System With Enlite Sensor.
II. Electronic Access DATES: Submit either electronic or • For written/paper comments
written comments on the collection of submitted to the Division of Dockets
Persons with access to the Internet
information by October 3, 2016. Management, FDA will post your
may obtain the documents at http://
ADDRESSES: You may submit comments comment, as well as any attachments,
www.fda.gov/MedicalDevices/
as follows: except for information submitted,
ProductsandMedicalProcedures/
marked and identified, as confidential,
DeviceApprovalsandClearances/ Electronic Submissions if submitted as detailed in
PMAApprovals/default.htm.
Submit electronic comments in the ‘‘Instructions.’’
Dated: August 1, 2016. Instructions: All submissions received
following way:
Leslie Kux, must include the Docket No. FDA–
• Federal eRulemaking Portal: http:// 2016–N–2066 for ‘‘Agency Information
Associate Commissioner for Policy.
www.regulations.gov. Follow the Collection Activities; Proposed
[FR Doc. 2016–18508 Filed 8–3–16; 8:45 am] instructions for submitting comments. Collection; Comment Request;
BILLING CODE 4164–01–P Comments submitted electronically, Certification of Identity for Freedom of
including attachments, to http:// Information Act and Privacy Act
www.regulations.gov will be posted to Requests.’’ Received comments will be
DEPARTMENT OF HEALTH AND the docket unchanged. Because your
HUMAN SERVICES placed in the docket and, except for
comment will be made public, you are those submitted as ‘‘Confidential
Food and Drug Administration solely responsible for ensuring that your Submissions,’’ publicly viewable at
comment does not include any http://www.regulations.gov or at the
confidential information that you or a Division of Dockets Management
[Docket No. FDA–2016–N–2066] third party may not wish to be posted, between 9 a.m. and 4 p.m., Monday
Agency Information Collection such as medical information, your or through Friday.
Activities; Proposed Collection; anyone else’s Social Security number, or • Confidential Submissions—To
Comment Request; Certification of confidential business information, such submit a comment with confidential
Identity for Freedom of Information Act as a manufacturing process. Please note information that you do not wish to be
and Privacy Act Requests that if you include your name, contact made publicly available, submit your
information, or other information that comments only as a written/paper
AGENCY: Food and Drug Administration, identifies you in the body of your submission. You should submit two
HHS. comments, that information will be copies total. One copy will include the
ACTION: Notice. posted on http://www.regulations.gov. information you claim to be confidential
• If you want to submit a comment with a heading or cover note that states
SUMMARY: The Food and Drug with confidential information that you ‘‘THIS DOCUMENT CONTAINS
Administration (FDA) is announcing an do not wish to be made available to the CONFIDENTIAL INFORMATION.’’ The
opportunity for public comment on the public, submit the comment as a Agency will review this copy, including
proposed collection of certain written/paper submission and in the the claimed confidential information, in
information by the Agency. Under the manner detailed (see ‘‘Written/Paper its consideration of comments. The
Paperwork Reduction Act of 1995 (the Submissions’’ and ‘‘Instructions’’). second copy, which will have the
PRA), Federal Agencies are required to Written/Paper Submissions claimed confidential information
publish notice in the Federal Register redacted/blacked out, will be available
sradovich on DSK3GMQ082PROD with NOTICES
concerning each proposed collection of Submit written/paper submissions as for public viewing and posted on http://
information and to allow 60 days for follows: www.regulations.gov. Submit both
public comment in response to the • Mail/Hand delivery/Courier (for copies to the Division of Dockets
notice. This notice solicits comments on written/paper submissions): Division of Management. If you do not wish your
‘‘Certification of Identity for Freedom of Dockets Management (HFA–305), Food name and contact information to be
Information Act and Privacy Act and Drug Administration, 5630 Fishers made publicly available, you can
Requests.’’ Lane, Rm. 1061, Rockville, MD 20852. provide this information on the cover
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![51456 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
sheet and not in the body of your Agencies to provide a 60-day notice in Act. The form is available at the
comments and you must identify this the Federal Register concerning each following FDA FOIA page at: http://
information as ‘‘confidential.’’ Any proposed collection of information www.fda.gov/RegulatoryInformation/
information marked as ‘‘confidential’’ before submitting the collection to OMB FOI/default.htm, although if an
will not be disclosed except in for approval. To comply with this individual requests one, we will send it
accordance with 21 CFR 10.20 and other requirement, FDA is publishing notice by mail or email. The FOIA grants the
applicable disclosure law. For more of the proposed collection of public a right to access Federal records
information about FDA’s posting of information set forth in this document. not normally prepared for public
comments to public dockets, see 80 FR With respect to the following distribution. The Privacy Act grants a
56469, September 18, 2015, or access collection of information, FDA invites right of access to members of the public
the information at: http://www.fda.gov/ comments on these topics: (1) Whether who seek access to one’s own records
regulatoryinformation/dockets/ the proposed collection of information that are maintained in an Agency’s
default.htm. is necessary for the proper performance system of records (i.e. the records are
Docket: For access to the docket to of FDA’s functions, including whether retrieved by that individual’s name or
read background documents or the the information will have practical other personal identifier). The statutes
electronic and written/paper comments utility; (2) the accuracy of FDA’s overlap, and individuals who request
received, go to http:// estimate of the burden of the proposed their own records are processed under
www.regulations.gov and insert the collection of information, including the both statutes. The Agency may need to
docket number, found in brackets in the validity of the methodology and confirm that the individual making the
heading of this document, into the assumptions used; (3) ways to enhance FOIA or Privacy Act request is indeed
‘‘Search’’ box and follow the prompts the quality, utility, and clarity of the the same person named in the Agency
and/or go to the Division of Dockets information to be collected; and (4) records.
Management, 5630 Fishers Lane, Rm. ways to minimize the burden of the
1061, Rockville, MD 20852. Members of the public who wish to
collection of information on access particular records will be asked
FOR FURTHER INFORMATION CONTACT: FDA respondents, including through the use for certain information: Name,
PRA Staff, Office of Operations, Food of automated collection techniques, citizenship status, social security
and Drug Administration, Three White when appropriate, and other forms of number, address, date of birth, place of
Flint North, 10A63, 11601 Landsdown information technology. birth, signature, and date of signature.
St., North Bethesda, MD 20851,
PRAStaff@fda.hhs.gov. Certification of Identity for Freedom of FDA estimates the burden of this
SUPPLEMENTARY INFORMATION: Under the
Information Act and Privacy Act collection of information as follows:
PRA (44 U.S.C. 3501–3520), Federal Requests OMB Control Number 0910— As stated in table 1, the estimates are
Agencies must obtain approval from the NEW based on the following: The number of
Office of Management and Budget In compliance with 44 U.S.C. 3507, FOIA and Privacy Act requests received
(OMB) for each collection of FDA will submit to the Office of by FDA each year that require a
information they conduct or sponsor. Management and Budget a request to certification of identity in order for FDA
‘‘Collection of information’’ is defined review and approve a new collection of to process the request. Of the 10,000
in 44 U.S.C. 3502(3) and 5 CFR information: Certification of Identity for requests received per year, only a small
1320.3(c) and includes Agency requests Freedom of Information Act and Privacy number require a certification of
or requirements that members of the Act Requests. This new form provides identity. In some cases, the requesters
public submit reports, keep records, or the FDA with data necessary to identify provide their own certification of
provide information to a third party. an individual requesting a particular identity. Therefore, we have estimated
Section 3506(c)(2)(A) of the PRA (44 record under the Freedom of the number of affected individuals at 60
U.S.C. 3506(c)(2)(A)) requires Federal Information Act (FOIA) and the Privacy per year.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA Form No. responses per burden per Total hours
respondents responses
respondent response
3975 ............................................................................ 60 1 60 .17 (10 minutes) ..... 10
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 28, 2016. DEPARTMENT OF HEALTH AND Preparedness and Response (ASPR)
Leslie Kux, HUMAN SERVICES within the U.S. Department of Health
Associate Commissioner for Policy. and Human Services (HHS), announces
Announcement of Requirements and the launch of the ‘‘MRC Serves’’ Video
[FR Doc. 2016–18463 Filed 8–3–16; 8:45 am]
Registration for the ‘‘MRC Serves’’ Challenge. The MRC is a national
BILLING CODE 4164–01–P
Video Challenge network of volunteers, organized locally
to improve the health and safety of their
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Office of the Secretary,
Department of Health and Human communities. MRC volunteers have
Services. medical, public health, other
ACTION: Notice.
backgrounds and have responded to
natural disasters, public health and
SUMMARY: The Medical Reserve Corps other emergencies, while also
(MRC) Program housed under the Office supporting community health activities.
of the Assistant Secretary for The MRC Program is looking for
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Document Created: 2016-08-04 02:53:26
Document Modified: 2016-08-04 02:53:26
| 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 October 3, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected] | |
| FR Citation | 81 FR 51455 |
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