82_FR_55604 82 FR 55381 - Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information

82 FR 55381 - Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 223 (November 21, 2017)

Page Range55381-55382
FR Document2017-25159

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 burden estimate for requests for a written statement from FDA regarding the classification and regulatory requirements that may be applicable to a particular device (513(g) requests).

Federal Register, Volume 82 Issue 223 (Tuesday, November 21, 2017) 
[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55381-55382]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0913]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 513(g) Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 burden estimate 
for requests for a written statement from FDA regarding the 
classification and regulatory requirements that may be applicable to a 
particular device (513(g) requests).

DATES: Submit either electronic or written comments on the collection 
of information by January 22, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 22, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2014-N-0913 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 513(g) Request for Information.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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,

[[Page 55382]]

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.

513(g) Request for Information

OMB Control Number 0910-0705--Extension

    Section 513(g) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining the 
Agency's views about the classification and regulatory requirements 
that may be applicable to a particular device. Section 513(g) provides 
that, within 60 days of the receipt of a written request of any person 
for information respecting the class in which a device has been 
classified or the requirements applicable to a device under the FD&C 
Act, the Secretary of Health and Human Services shall provide such 
person a written statement of the classification (if any) of such 
device and the requirements of the FD&C Act applicable to the device.
    The guidance document entitled ``FDA and Industry Procedures for 
Section 513(g) Requests for Information Under the Federal Food, Drug, 
and Cosmetic Act; Guidance for Industry and Food and Drug 
Administration Staff'' establishes procedures for submitting, 
reviewing, and responding to requests for information respecting the 
class in which a device has been classified or the requirements 
applicable to a device under the FD&C Act that are submitted in 
accordance with section 513(g) of the FD&C Act. FDA does not review 
data related to substantial equivalence or safety and effectiveness in 
a 513(g) request for information. FDA's responses to 513(g) requests 
for information are not device classification decisions and do not 
constitute FDA clearance or approval for marketing. Classification 
decisions and clearance or approval for marketing require submissions 
under different sections of the FD&C Act.
    Additionally, the FD&C Act, as amended by the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to 
collect user fees for 513(g) requests for information. The guidance 
document entitled ``Guidance for Industry and Food and Drug 
Administration Staff; User Fees for 513(g) Requests for Information'' 
assists FDA staff and regulated industry by describing the user fees 
associated with 513(g) requests. The Medical Device User Fee Cover 
Sheet (Form FDA 3601), which accompanies the supplemental material 
described in this information collection is approved under OMB control 
number 0910-0511 and expires August 31, 2019.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
CDRH 513(g) requests............             114               1             114              12           1,368
CBER 513(g) requests............               4               1               4              12              48
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,416
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\1\ There are no capital costs of operating and maintenance costs associated with this collection off
  information.

    Respondents of this collection of information are mostly device 
manufacturers; however, anyone may submit a 513(g) request for 
information. The total number of annual responses is based on the 
average number of 513(g) requests received each year by the Agency.

    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-25159 Filed 11-20-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices 55381 Since the last approval of this if they are postmarked or the delivery made publicly available, submit your information collection, we have updated service acceptance receipt is on or comments only as a written/paper the estimated number of respondents before that date. submission. You should submit two from 20 to 10 respondents per year, copies total. One copy will include the Electronic Submissions based on the reduced number of information you claim to be confidential notifications received in recent years. Submit electronic comments in the with a heading or cover note that states This adjustment has resulted in a 150- following way: ‘‘THIS DOCUMENT CONTAINS hour reduction to the total hour burden • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The estimate. https://www.regulations.gov. Follow the Agency will review this copy, including instructions for submitting comments. the claimed confidential information, in Dated: November 9, 2017. Comments submitted electronically, its consideration of comments. The Anna K. Abram, including attachments, to https:// second copy, which will have the Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to claimed confidential information Legislation, and Analysis. the docket unchanged. Because your redacted/blacked out, will be available [FR Doc. 2017–25158 Filed 11–20–17; 8:45 am] comment will be made public, you are for public viewing and posted on BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit comment does not include any both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and DEPARTMENT OF HEALTH AND third party may not wish to be posted, contact information to be made publicly HUMAN SERVICES such as medical information, your or available, you can provide this anyone else’s Social Security number, or information on the cover sheet and not Food and Drug Administration confidential business information, such in the body of your comments and you [Docket No. FDA–2014–N–0913] as a manufacturing process. Please note must identify this information as that if you include your name, contact ‘‘confidential.’’ Any information marked Agency Information Collection information, or other information that as ‘‘confidential’’ will not be disclosed Activities; Proposed Collection; identifies you in the body of your except in accordance with 21 CFR 10.20 Comment Request; 513(g) Request for comments, that information will be and other applicable disclosure law. For Information posted on https://www.regulations.gov. more information about FDA’s posting AGENCY: Food and Drug Administration, • If you want to submit a comment of comments to public dockets, see 80 HHS. with confidential information that you FR 56469, September 18, 2015, or access do not wish to be made available to the the information at: https://www.gpo.gov/ ACTION: Notice. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- SUMMARY: The Food and Drug written/paper submission and in the 23389.pdf. Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper Docket: For access to the docket to announcing an opportunity for public Submissions’’ and ‘‘Instructions’’). read background documents or the comment on the proposed collection of Written/Paper Submissions electronic and written/paper comments certain information by the Agency. received, go to https:// Under the Paperwork Reduction Act of Submit written/paper submissions as www.regulations.gov and insert the 1995 (PRA), Federal Agencies are follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for heading of this document, into the required to publish notice in the written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts Federal Register concerning each Management Staff (HFA–305), Food and and/or go to the Dockets Management proposed collection of information, Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. existing collection of information, and • For written/paper comments to allow 60 days for public comment in FOR FURTHER INFORMATION CONTACT: submitted to the Dockets Management response to the notice. This notice Amber Sanford, Office of Operations, Staff, FDA will post your comment, as solicits comments on the information Food and Drug Administration, Three well as any attachments, except for collection burden estimate for requests White Flint North, 10A–12M, 11601 information submitted, marked and for a written statement from FDA Landsdown St., North Bethesda, MD identified, as confidential, if submitted regarding the classification and 20852, 301–796–8867, PRAStaff@ as detailed in ‘‘Instructions.’’ regulatory requirements that may be Instructions: All submissions received fda.hhs.gov. applicable to a particular device (513(g) must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the requests). 2014–N–0913 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal DATES: Submit either electronic or Collection Activities; Proposed Agencies must obtain approval from the written comments on the collection of Collection; Comment Request; 513(g) Office of Management and Budget information by January 22, 2018. Request for Information.’’ Received (OMB) for each collection of ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor. as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR asabaliauskas on DSKBBXCHB2PROD with NOTICES considered. Electronic comments must submitted as ‘‘Confidential 1320.3(c) and includes Agency requests be submitted on or before January 22, Submissions,’’ publicly viewable at or requirements that members of the 2018. The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or electronic filing system will accept Dockets Management Staff between 9 provide information to a third party. comments until midnight Eastern Time a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44 at the end of January 22, 2018. Friday. U.S.C. 3506(c)(2)(A)) requires Federal Comments received by mail/hand • Confidential Submissions—To Agencies to provide a 60-day notice in delivery/courier (for written/paper submit a comment with confidential the Federal Register concerning each submissions) will be considered timely information that you do not wish to be proposed collection of information, VerDate Sep<11>2014 18:56 Nov 20, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1

55382 Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices including each proposed extension of an (21 U.S.C. 360c(g)) provides a means for FDA’s responses to 513(g) requests for existing collection of information, obtaining the Agency’s views about the information are not device classification before submitting the collection to OMB classification and regulatory decisions and do not constitute FDA for approval. To comply with this requirements that may be applicable to clearance or approval for marketing. requirement, FDA is publishing notice a particular device. Section 513(g) Classification decisions and clearance or of the proposed collection of provides that, within 60 days of the approval for marketing require information set forth in this document. receipt of a written request of any submissions under different sections of With respect to the following person for information respecting the the FD&C Act. collection of information, FDA invites class in which a device has been comments on these topics: (1) Whether classified or the requirements applicable Additionally, the FD&C Act, as the proposed collection of information to a device under the FD&C Act, the amended by the Food and Drug is necessary for the proper performance Secretary of Health and Human Services Administration Amendments Act of of FDA’s functions, including whether shall provide such person a written 2007 (Pub. L. 110–85), requires FDA to the information will have practical statement of the classification (if any) of collect user fees for 513(g) requests for utility; (2) the accuracy of FDA’s such device and the requirements of the information. The guidance document estimate of the burden of the proposed FD&C Act applicable to the device. entitled ‘‘Guidance for Industry and collection of information, including the The guidance document entitled Food and Drug Administration Staff; validity of the methodology and ‘‘FDA and Industry Procedures for User Fees for 513(g) Requests for assumptions used; (3) ways to enhance Section 513(g) Requests for Information Information’’ assists FDA staff and the quality, utility, and clarity of the Under the Federal Food, Drug, and regulated industry by describing the information to be collected; and (4) Cosmetic Act; Guidance for Industry user fees associated with 513(g) ways to minimize the burden of the and Food and Drug Administration requests. The Medical Device User Fee collection of information on Staff’’ establishes procedures for Cover Sheet (Form FDA 3601), which respondents, including through the use submitting, reviewing, and responding accompanies the supplemental material of automated collection techniques, to requests for information respecting described in this information collection when appropriate, and other forms of the class in which a device has been is approved under OMB control number information technology. classified or the requirements applicable 0910–0511 and expires August 31, 2019. 513(g) Request for Information to a device under the FD&C Act that are submitted in accordance with section FDA estimates the burden of this OMB Control Number 0910–0705— 513(g) of the FD&C Act. FDA does not collection of information as follows: Extension review data related to substantial Section 513(g) of the Federal Food, equivalence or safety and effectiveness Drug, and Cosmetic Act (the FD&C Act) in a 513(g) request for information. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of Average Number of Total annual Activity responses per burden per Total hours respondents responses respondent response CDRH 513(g) requests ........................................................ 114 1 114 12 1,368 CBER 513(g) requests ......................................................... 4 1 4 12 48 Total .............................................................................. ........................ ........................ ........................ ........................ 1,416 1 There are no capital costs of operating and maintenance costs associated with this collection off information. Respondents of this collection of DEPARTMENT OF HEALTH AND adoption of HRSA’s core clinical oral information are mostly device HUMAN SERVICES health competencies for non-dental manufacturers; however, anyone may health care providers in Health Center submit a 513(g) request for information. Health Resources and Services (HC) settings, focusing on services for The total number of annual responses is Administration pregnant women and children. based on the average number of 513(g) SUPPLEMENTARY INFORMATION: Supplemental Award to the National requests received each year by the Intended Recipient of the Award: Network for Oral Health Access Agency. National Network for Oral Health Dated: November 9, 2017. AGENCY: Health Resources and Services Access. Administration, HHS. Amount of Non-Competitive Awards: Anna K. Abram, ACTION: Notice. $250,000. Deputy Commissioner for Policy, Planning, Budget Periods of Supplemental Legislation, and Analysis. SUMMARY: HRSA announces the award Funding: July 1, 2017, through June 30, [FR Doc. 2017–25159 Filed 11–20–17; 8:45 am] 2018. asabaliauskas on DSKBBXCHB2PROD with NOTICES of a supplement in the amount of BILLING CODE 4164–01–P $250,000 for a HRSA-funded CFDA Number: 93.110. cooperative agreement awarded to the Authority: Special Projects of National Network for Oral Health Regional and National Significance Access (NNOHA). The supplement, program (Social Security Act, Title V, awarded on September 25, 2017, will § 501(a)(2) (42 U.S.C. 701(a)(2)). fund demonstration projects to increase Justification: The National Network the integration of oral health and for Oral Health Access (NNOHA) primary care practice through the supports goals to improve access to oral VerDate Sep<11>2014 18:56 Nov 20, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1


Document Created: 2017-11-21 00:42:58
Document Modified: 2017-11-21 00:42:58
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.
DatesSubmit either electronic or written comments on the collection of information by January 22, 2018.
ContactAmber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation82 FR 55381 
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