Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories, 13296-13298 [2019-06551]

Download as PDF jbell on DSK30RV082PROD with NOTICES 13296 Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The Advisory Board’s charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered under Executive Order 13811 on February 12, 2018, and will terminate on September 30, 2019. Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. Matters To Be Considered: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; SEC Petitions for: Sandia National Laboratory (Albuquerque, New Mexico, 1997– 2011), Area IV Santa Susanna Field Laboratory (Ventura County, California, 1991–1993), Superior Steel Company (Carnegie, Pennsylvania), and Idaho National Laboratory (Scoville, Idaho, 1963–1970); and a Board Work Session. Agenda items are subject to change as priorities dictate. The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and VerDate Sep<11>2014 17:25 Apr 03, 2019 Jkt 247001 Prevention and the Agency for Toxic Substances and Disease Registry. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–06602 Filed 4–3–19; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Interagency Committee on Smoking and Health (ICSH); Notice of Charter Renewal Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of charter renewal. AGENCY: This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Interagency Committee on Smoking and Health, Department of Health and Human Services, has been renewed for a 2-year period through March 20, 2021. FOR FURTHER INFORMATION CONTACT: Simon McNabb, Designated Federal Officer, Interagency Committee on Smoking and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, Patriot’s Plaza, 395 E Street SW, M/S P06, Washington, DC 20201, telephone (202) 245–0550, Email: BOL1@cdc.gov. The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. SUMMARY: Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–06605 Filed 4–3–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1593] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 ACTION: Notice. 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 information collections regarding medical device accessories requests. DATES: Submit either electronic or written comments on the collection of information by June 3, 2019. 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 June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 3, 2019. 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. SUMMARY: 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’’). E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices jbell on DSK30RV082PROD with NOTICES 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– 2016–N–1593 for ‘‘Medical Device Accessories.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 VerDate Sep<11>2014 17:25 Apr 03, 2019 Jkt 247001 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, 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. 13297 OMB Control Number 0910–0823— Extension FDA’s guidance document ‘‘Medical Device Accessories—Describing Accessories and Classification Pathways’’ (the Accessories guidance) 1 is intended to provide guidance to industry and FDA staff about the regulation of accessories to medical devices, to describe FDA’s policy concerning the classification of accessories, and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices. In addition, the guidance explains what devices FDA generally considers an ‘‘accessory’’ and describes the processes under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)) to allow requests for risk- and regulatory control-based classification of accessories. We are requesting OMB approval to revise this information collection request (ICR) by adding burden estimates for two new accessory classification pathways created by the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115–52). FDARA changed how FDA regulates medical device accessories. Specifically, section 707 of FDARA added section 513(f)(6) to the statute and requires that FDA, upon request, classify existing and new accessories notwithstanding the classification of any other device with which such accessory is intended to be used. This means that the classification of an accessory may not be the same as its parent device, depending on the risks of the accessory when used as intended and the level of regulatory controls necessary for reasonable assurance of safety and effectiveness of the accessory. Until an accessory is distinctly classified, its existing classification will continue to apply. This provision does not preclude a manufacturer from submitting a De Novo request for an accessory. When the Accessories guidance originally issued, FDA encouraged the use of the De Novo classification process to allow manufacturers to request risk- and regulatory controlbased classification of accessories of a new type. FDA’s recommendations in the guidance represented a new information collection as an accessory classification De Novo request. The information collected for an accessory classification De Novo request is substantially the same as a De Novo request (since approved under OMB control number 0910–0844), is submitted in the same manner, and has the same estimated information collection burden. The burden estimate associated with ‘‘De Novo request under 21 U.S.C. 513(f)(2)(i)’’ and ‘‘De Novo request under 21 U.S.C. 513(f)(2)(ii),’’ in 1 The guidance document is available on FDA’s website (https://www.fda.gov/ucm/groups/fdagov- public/@fdagov-meddev-gen/documents/document/ ucm429672.pdf). Medical Device Accessories PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1 13298 Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices OMB control number 0910–0844, includes De Novo requests for accessories. We have determined that the burden estimate for ‘‘Accessory Classification De Novo Requests’’ in this ICR (Accessory Classification Requests; OMB control number 0910–0823) is redundant and have, therefore, removed it. Depending on an accessory’s regulatory history, there are different submission types, tracking mechanisms, and deadlines: (1) Existing accessory types are those that have been identified in a classification regulation or granted marketing authorization as part of a 510(k), pre-market application (PMA), or De Novo request (approved under OMB control numbers 0910–0120, 0910–0231, and 0910–0844, respectively). Manufacturers with marketing authorization for an existing accessory may request appropriate classification through a new stand-alone premarket submission (Existing Accessory Request). Upon request, FDA is required to meet with a manufacturer or importer to discuss the appropriate classification of an existing accessory prior to submitting a written request. Existing Accessory Requests will be initially tracked as ‘‘Q-submissions’’ (approved under OMB control number 0910–0756). FDA has a statutory deadline of 85 calendar days to respond to an Existing Accessory Request. (2) New accessory types are those that have not been granted marketing authorization as part of a 510(k), PMA, or De Novo request. Manufacturers may include new accessories into a 510(k) or PMA with the parent device (New Accessory Request). New Accessory Requests will have the same deadline as the 510(k) or PMA. Therefore, new accessory types should follow the applicable Medical Device User Fee Amendments of 2017 deadline for the parent submission. The decision for New Accessory Requests will be separate from the decision for the marketing application. For both Existing and New Accessory Requests, manufacturers must request proper classification of their accessory in the submission and include draft special controls, if requesting classification into class II. The processes that we use to classify an accessory will be like those used for De Novo requests. If FDA grants the Accessory Request, FDA must issue an order establishing a new classification regulation for the accessory type. If FDA denies the Accessory Request, FDA must issue a letter with a detailed description and justification for our determination. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Total annual responses Average burden per response Total hours Existing Accessory Request .................................................................... New Accessory Request .......................................................................... 15 10 1 1 15 10 40 40 600 400 Total .................................................................................................. .................... .................... .................... .................... 1,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We expect to receive approximately 15 Existing Accessory Requests and 10 New Accessory Requests per year. Based on estimates by FDA administrative and technical staff who are familiar with the submission process for accessory classification requests, we estimate that the ‘‘Average Burden per Response’’ for both Existing and New Accessory Requests will be approximately 40 hours per submission. Our estimated burden for the information collection reflects an overall decrease of 440 hours and an increase of 17 responses. Factors contributing to the revision of the burden estimate include the addition of the two new accessory classification pathways created by FDARA and the removal of redundant burden described earlier in this document. jbell on DSK30RV082PROD with NOTICES Number of responses per respondent Dated: March 29, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06551 Filed 4–3–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:25 Apr 03, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–3412] Determination That QVAR 40 and QVAR 80 (Beclomethasone Dipropionate HFA) Inhalation Aerosol, 40 Micrograms and 80 Micrograms, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, if all other legal and regulatory requirements are met. SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993–0002, 301– 796–3507. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13296-13298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06551]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1593]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 information collections regarding medical 
device accessories requests.

DATES: Submit either electronic or written comments on the collection 
of information by June 3, 2019.

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 June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 3, 2019. 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'').

[[Page 13297]]

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-2016-N-1593 for ``Medical Device Accessories.'' 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.gpo.gov/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, 
[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, 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.

Medical Device Accessories

OMB Control Number 0910-0823--Extension

    FDA's guidance document ``Medical Device Accessories--Describing 
Accessories and Classification Pathways'' (the Accessories guidance) 
\1\ is intended to provide guidance to industry and FDA staff about the 
regulation of accessories to medical devices, to describe FDA's policy 
concerning the classification of accessories, and to discuss the 
application of this policy to devices that are commonly used as 
accessories to other medical devices. In addition, the guidance 
explains what devices FDA generally considers an ``accessory'' and 
describes the processes under section 513(f)(6) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)) to allow 
requests for risk- and regulatory control-based classification of 
accessories.
---------------------------------------------------------------------------

    \1\ The guidance document is available on FDA's website (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429672.pdf).
---------------------------------------------------------------------------

    We are requesting OMB approval to revise this information 
collection request (ICR) by adding burden estimates for two new 
accessory classification pathways created by the FDA Reauthorization 
Act of 2017 (FDARA) (Pub. L. 115-52).
    FDARA changed how FDA regulates medical device accessories. 
Specifically, section 707 of FDARA added section 513(f)(6) to the 
statute and requires that FDA, upon request, classify existing and new 
accessories notwithstanding the classification of any other device with 
which such accessory is intended to be used. This means that the 
classification of an accessory may not be the same as its parent 
device, depending on the risks of the accessory when used as intended 
and the level of regulatory controls necessary for reasonable assurance 
of safety and effectiveness of the accessory. Until an accessory is 
distinctly classified, its existing classification will continue to 
apply. This provision does not preclude a manufacturer from submitting 
a De Novo request for an accessory.
    When the Accessories guidance originally issued, FDA encouraged the 
use of the De Novo classification process to allow manufacturers to 
request risk- and regulatory control-based classification of 
accessories of a new type. FDA's recommendations in the guidance 
represented a new information collection as an accessory classification 
De Novo request. The information collected for an accessory 
classification De Novo request is substantially the same as a De Novo 
request (since approved under OMB control number 0910-0844), is 
submitted in the same manner, and has the same estimated information 
collection burden. The burden estimate associated with ``De Novo 
request under 21 U.S.C. 513(f)(2)(i)'' and ``De Novo request under 21 
U.S.C. 513(f)(2)(ii),'' in

[[Page 13298]]

OMB control number 0910-0844, includes De Novo requests for 
accessories. We have determined that the burden estimate for 
``Accessory Classification De Novo Requests'' in this ICR (Accessory 
Classification Requests; OMB control number 0910-0823) is redundant and 
have, therefore, removed it.
    Depending on an accessory's regulatory history, there are different 
submission types, tracking mechanisms, and deadlines:
    (1) Existing accessory types are those that have been identified in 
a classification regulation or granted marketing authorization as part 
of a 510(k), pre-market application (PMA), or De Novo request (approved 
under OMB control numbers 0910-0120, 0910-0231, and 0910-0844, 
respectively). Manufacturers with marketing authorization for an 
existing accessory may request appropriate classification through a new 
stand-alone premarket submission (Existing Accessory Request). Upon 
request, FDA is required to meet with a manufacturer or importer to 
discuss the appropriate classification of an existing accessory prior 
to submitting a written request. Existing Accessory Requests will be 
initially tracked as ``Q-submissions'' (approved under OMB control 
number 0910-0756). FDA has a statutory deadline of 85 calendar days to 
respond to an Existing Accessory Request.
    (2) New accessory types are those that have not been granted 
marketing authorization as part of a 510(k), PMA, or De Novo request. 
Manufacturers may include new accessories into a 510(k) or PMA with the 
parent device (New Accessory Request). New Accessory Requests will have 
the same deadline as the 510(k) or PMA. Therefore, new accessory types 
should follow the applicable Medical Device User Fee Amendments of 2017 
deadline for the parent submission. The decision for New Accessory 
Requests will be separate from the decision for the marketing 
application.
    For both Existing and New Accessory Requests, manufacturers must 
request proper classification of their accessory in the submission and 
include draft special controls, if requesting classification into class 
II. The processes that we use to classify an accessory will be like 
those used for De Novo requests. If FDA grants the Accessory Request, 
FDA must issue an order establishing a new classification regulation 
for the accessory type. If FDA denies the Accessory Request, FDA must 
issue a letter with a detailed description and justification for our 
determination.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of
                                                  Number of    responses      Total       Average
                    Activity                     respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
----------------------------------------------------------------------------------------------------------------
Existing Accessory Request.....................           15            1           15           40          600
New Accessory Request..........................           10            1           10           40          400
                                                ----------------------------------------------------------------
    Total......................................  ...........  ...........  ...........  ...........        1,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We expect to receive approximately 15 Existing Accessory Requests 
and 10 New Accessory Requests per year. Based on estimates by FDA 
administrative and technical staff who are familiar with the submission 
process for accessory classification requests, we estimate that the 
``Average Burden per Response'' for both Existing and New Accessory 
Requests will be approximately 40 hours per submission.
    Our estimated burden for the information collection reflects an 
overall decrease of 440 hours and an increase of 17 responses. Factors 
contributing to the revision of the burden estimate include the 
addition of the two new accessory classification pathways created by 
FDARA and the removal of redundant burden described earlier in this 
document.

    Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06551 Filed 4-3-19; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.