Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements, 37314-37315 [2019-16244]

Download as PDF 37314 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https:// userfees.fda.gov/pay. (Note: Only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, click ‘‘Pay Now’’ to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards. 2. If paying with a paper check: Checks must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. Payments can be mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197–9000. If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact the U.S. Bank at 314–418–4013). 3. When paying by wire transfer, the invoice number must be included. Without the invoice number the payment may not be applied. Regarding re-inspection fees, if the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that the outsourcing facility add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA’s tax identification number is 53–0196965. Dated: July 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16253 Filed 7–30–19; 8:45 am] jbell on DSK3GLQ082PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1203] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 August 30, 2019. 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0661. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements OMB Control Number 0910–0661— Extension Under section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)), as amended by section 3052 of the 21st Century Cures Act (Cures Act) (Pub. L. 114–255), FDA is authorized to exempt a humanitarian VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 use device (HUD) from the effectiveness requirements in sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States; (2) would not be available to a person with such a disease or condition unless the exemption is granted and there is no comparable device, other than another HUD approved under this exemption, available to treat or diagnose the disease or condition; and (3) the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from using the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. HUDs approved under a humanitarian device exemption (HDE) cannot be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i.e., for profit), except in narrow circumstances. Under section 520(m)(6)(A)(i) of the FD&C Act, a HUD approved under an HDE is eligible to be sold for profit if the device meets the following criteria: The device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or the device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe. Section 520(m)(6)(A)(ii) of the FD&C Act, provides that the Secretary of Health and Human Services will determine the annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit. The Cures Act amended the FD&C Act definition of the ADN as the number of devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. Section 520(m)(6)(A)(iii) of the FD&C Act provides that an HDE holder immediately notify the Agency if the number of such devices distributed during any calendar year exceeds the ADN. Section 520(m)(6)(C) of the FD&C Act provides that an HDE holder may petition to modify the ADN if additional information arises. E:\FR\FM\31JYN1.SGM 31JYN1 37315 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices FDA is requesting the extension of OMB approval for the collection of information required under the statutory mandate of sections 515A (21 U.S.C. 360e–1) and 520(m) of the FD&C Act. In the Federal Register of March 12, 2019 (84 FR 8874), FDA published a 60day 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: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity/section of FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Cures Act Pediatric Subpopulation and Patient Information— 515A(a)(2) of the FD&C Act ............................................. Exemption from Profit Prohibition Information— 520(m)(6)(A)(i) and (ii) of the FD&C Act .......................... Request for Determination of Eligibility Criteria—613(b) of FDASIA ............................................................................. ADN Notification—520(m)(6)(A)(iii) of the FD&C Act .......... ADN Modification—520(m)(6)(C) of the FD&C Act ............. Total .............................................................................. 1 There Dated: July 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16244 Filed 7–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–4319] Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System Food and Drug Administration, 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 SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Total hours 1 1 1 100 100 1 1 1 50 50 1 1 1 1 1 1 1 1 1 10 100 100 10 100 100 ........................ ........................ ........................ ........................ 360 VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 response to the notice. This notice solicits comments on information collection associated with the Unique Device Identification System. DATES: Submit either electronic or written comments on the collection of information by September 30, 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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 30, 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 HHS. ACTION: Average burden per response Total annual responses are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects a decrease in the number of responses and corresponding decrease of 1,010 hours in the total burden since our last OMB approval. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. AGENCY: Number of responses per respondent Number of respondents 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 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 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– 2016–N–4319 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System.’’ 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 E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37314-37315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16244]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1203]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Information To 
Accompany Humanitarian Device Exemption Applications and Annual 
Distribution Number Reporting Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 August 
30, 2019.

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 0910-0661. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

Information To Accompany Humanitarian Device Exemption Applications and 
Annual Distribution Number Reporting Requirements

OMB Control Number 0910-0661--Extension

    Under section 520(m) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360j(m)), as amended by section 3052 of the 21st 
Century Cures Act (Cures Act) (Pub. L. 114-255), FDA is authorized to 
exempt a humanitarian use device (HUD) from the effectiveness 
requirements in sections 514 and 515 of the FD&C Act (21 U.S.C. 360d 
and 360e) provided that the device: (1) Is designed to treat or 
diagnose a disease or condition that affects not more than 8,000 
individuals in the United States; (2) would not be available to a 
person with such a disease or condition unless the exemption is granted 
and there is no comparable device, other than another HUD approved 
under this exemption, available to treat or diagnose the disease or 
condition; and (3) the device will not expose patients to an 
unreasonable or significant risk of illness or injury and the probable 
benefit to health from using the device outweighs the risk of injury or 
illness from its use, taking into account the probable risks and 
benefits of currently available devices or alternative forms of 
treatment.
    HUDs approved under a humanitarian device exemption (HDE) cannot be 
sold for an amount that exceeds the costs of research and development, 
fabrication, and distribution of the device (i.e., for profit), except 
in narrow circumstances. Under section 520(m)(6)(A)(i) of the FD&C Act, 
a HUD approved under an HDE is eligible to be sold for profit if the 
device meets the following criteria: The device is intended for the 
treatment or diagnosis of a disease or condition that occurs in 
pediatric patients or in a pediatric subpopulation, and such device is 
labeled for use in pediatric patients or in a pediatric subpopulation 
in which the disease or condition occurs; or the device is intended for 
the treatment or diagnosis of a disease or condition that does not 
occur in pediatric patients, or that occurs in pediatric patients in 
such numbers that the development of the device for such patients is 
impossible, highly impracticable, or unsafe.
    Section 520(m)(6)(A)(ii) of the FD&C Act, provides that the 
Secretary of Health and Human Services will determine the annual 
distribution number (ADN) for devices that meet the eligibility 
criteria to be permitted to be sold for profit. The Cures Act amended 
the FD&C Act definition of the ADN as the number of devices reasonably 
needed to treat, diagnose, or cure a population of 8,000 individuals in 
the United States.
    Section 520(m)(6)(A)(iii) of the FD&C Act provides that an HDE 
holder immediately notify the Agency if the number of such devices 
distributed during any calendar year exceeds the ADN. Section 
520(m)(6)(C) of the FD&C Act provides that an HDE holder may petition 
to modify the ADN if additional information arises.

[[Page 37315]]

    FDA is requesting the extension of OMB approval for the collection 
of information required under the statutory mandate of sections 515A 
(21 U.S.C. 360e-1) and 520(m) of the FD&C Act.
    In the Federal Register of March 12, 2019 (84 FR 8874), 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:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Activity/section of FD&C Act, as
  amended by the Food and Drug                       Number of                        Average
    Administration Safety and        Number of     responses per   Total annual     burden per      Total hours
 Innovation Act (FDASIA) and the    respondents     respondent       responses       response
            Cures Act
----------------------------------------------------------------------------------------------------------------
Pediatric Subpopulation and                    1               1               1             100             100
 Patient Information--515A(a)(2)
 of the FD&C Act................
Exemption from Profit                          1               1               1              50              50
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   1               1               1              10              10
 Eligibility Criteria--613(b) of
 FDASIA.........................
ADN Notification--                             1               1               1             100             100
 520(m)(6)(A)(iii) of the FD&C
 Act............................
ADN Modification--520(m)(6)(C)                 1               1               1             100             100
 of the FD&C Act................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects a 
decrease in the number of responses and corresponding decrease of 1,010 
hours in the total burden since our last OMB approval. We attribute 
this adjustment to a decrease in the number of submissions we received 
over the last few years.

    Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16244 Filed 7-30-19; 8:45 am]
 BILLING CODE 4164-01-P

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