82 FR 14518 - Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 53 (March 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 53 (March 21, 2017)
| Page Range | 14518-14520 | |
| FR Document | 2017-05349 |
[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)] [Notices] [Pages 14518-14520] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05349] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1066] Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption 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, 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 collection associated with the annual reporting for custom devices. DATES: Submit either electronic or written comments on the collection of information by May 22, 2017. ADDRESSES: You may submit comments as follows: 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 [[Page 14519]] 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): 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-2017-N-1066 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. 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. Annual Reporting for Custom Device Exemption OMB Control Number 0910-0767--Extension The custom device exemption is set forth at section 520(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(b)(2)(B)). A custom device is in a narrow category of device that, by virtue of the rarity of the patient's medical condition or physician's special need the device is designed to treat, it would be impractical for the device to comply with premarket review regulations and performance standards. The Food and Drug Administration Safety and Innovation Act (FDASIA) implemented changes to the custom device exemption contained in section 520(b) of the FD&C Act. The new provision amended the existing custom device exemption and introduced new concepts and procedures for custom devices, such as: Devices created or modified in order to comply with the order of an individual physician or dentist; the potential for multiple units of a device type (limited to no more than five units per year) qualifying for the custom device exemption; and annual reporting requirements by the manufacturer to FDA about devices manufactured and distributed under section 520(b) of the FD&C Act. Under FDASIA, ``devices'' that qualify for the custom device exemption contained in section 520(b) of the FD&C Act were clarified to include no more than ``five units per year of a particular device type'' that otherwise meet all the requirements necessary to qualify for the custom device exemption. In the Federal Register of September 24, 2014 (79 FR 57112), FDA announced the availability of the guidance entitled ``Custom Device Exemption.'' FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of the guidance is to define terms used in the custom device exemption, explain how to interpret the ``five units per year of a particular device type'' language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to [[Page 14520]] submit an annual report for devices distributed under the custom device exemption. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Annual reporting for custom devices................................ 33 1 33 40 1,320 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05349 Filed 3-20-17; 8:45 am] BILLING CODE 4164-01-P
![14518 Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Notices
individual during an interview. The 2,820. (For policy questions regarding collection contact Carla Patterson at
CMS–43 application follows the this collection contact Ivan Iveljic at 410–786–8911.)
questions and requirements used by 410–786–3312.) Dated: March 16, 2017.
SSA to determine Title II eligibility. 5. Type of Information Collection
William N. Parham, III,
This is done not only for consistency Request: Extension without change of a
currently approved collection; Title of Director, Paperwork Reduction Staff, Office
purposes, but because certain Title II of Strategic Operations and Regulatory
and Title XVIII insured status and Information Collection: Medicaid Affairs.
relationship requirements must be met Payment for Prescription Drugs—
[FR Doc. 2017–05535 Filed 3–20–17; 8:45 am]
in order to qualify for Medicare under Physicians and Hospital Outpatient
BILLING CODE 4120–01–P
the end stage renal disease provisions. Departments Collecting and Submitting
Form Number: CMS–43 (OMB control Drug Identifying Information to State
number: 0938–0800); Frequency: Once; Medicaid Programs; Use: States are
DEPARTMENT OF HEALTH AND
Affected Public: Individuals or required to provide for the collection
HUMAN SERVICES
households; Number of Respondents: and submission of utilization data for
25,000; Total Annual Responses: certain physician-administered drugs in Food and Drug Administration
25,000; Total Annual Hours: 10,400. order to receive federal financial
(For policy questions regarding this participation for these drugs. [Docket No. FDA–2017–N–1066]
collection contact Carla Patterson at Physicians, serving as respondents to
states, submit National Drug Code Agency Information Collection
410–786–8911.)
3. Type of Information Collection numbers and utilization information for Activities; Proposed Collection;
Request: Extension without change of a ‘‘J’’ code physician-administered drugs Comment Request; Annual Reporting
currently approved collection; Title of so that the states will have sufficient for Custom Device Exemption
Information Collection: Request for information to collect drug rebate AGENCY: Food and Drug Administration,
Termination of Premium Hospital and dollars. Form Number: CMS–10215 HHS.
Supplementary Medical Insurance; Use: (OMB control number: 0938–1026);
ACTION: Notice.
The CMS–1763 form provides us and Frequency: Weekly; Affected Public:
the Social Security Administration Business or other for-profits and Not- SUMMARY: The Food and Drug
(SSA) with the enrollee’s request for for-profit institutions); Number of Administration (FDA) is announcing an
termination of Part B, Part A or both Respondents: 20,000; Total Annual opportunity for public comment on the
Part B and A premium coverage. The Responses: 3,910,000; Total Annual proposed collection of certain
form is completed by an SSA claims or Hours: 16,227. (For policy questions information by the Agency. Under the
field representative using information regarding this collection contact Lisa Paperwork Reduction Act of 1995 (the
provided by the Medicare enrollee Ferrandi at 410–786–5445.) PRA), Federal Agencies are required to
during an interview. The purpose of the 6. Type of Information Collection publish notice in the Federal Register
form is to provide to the enrollee with Request: Extension without change of a concerning each proposed collection of
a standardized format to request currently approved collection; Title of information, including each proposed
termination of Part B, Part A premium Information Collection: Request for extension of an existing collection of
coverage or both, explain why the Retirement Benefit Information; Use: information, and to allow 60 days for
enrollee wishes to terminate such Section 1818(d)(5) of the Social Security public comment in response to the
coverage, and to acknowledge that the Act provides that former state and local notice. This notice solicits comments on
ramifications of the decision are government employees (who are age 65 information collection associated with
understood. Form Number: CMS–1763 or older, have been entitled to Premium the annual reporting for custom devices.
(OMB control number: 0938–0025); Part A for at least 7 years, and did not
have the premium paid for by a state, a DATES: Submit either electronic or
Frequency: Once; Affected Public:
Individuals or households; Number of political subdivision of a state, or an written comments on the collection of
Respondents: 101,000; Total Annual agency or instrumentality of one or information by May 22, 2017.
Responses: 101,000; Total Annual more states or political subdivisions) ADDRESSES: You may submit comments
Hours: 16,867. (For policy questions may have the Part A premium reduced as follows:
regarding this collection contact Carla to zero. These individuals must also Electronic Submissions
Patterson at 410–786–8911.) have 10 years of employment with the
4. Type of Information Collection state or local government employer or a Submit electronic comments in the
Request: Revision of a currently combination of 10 years of employment following way:
approved collection; Title of with a state or local government • Federal eRulemaking Portal:
Information Collection: Collection of employer and a non-government https://www.regulations.gov. Follow the
Prescription Drug Event Data from employer. The CMS–R–285 form is an instructions for submitting comments.
Contracted Part D Providers for essential part of the process of Comments submitted electronically,
Payment; Use: The collected determining whether an individual including attachments, to https://
information is used primarily for qualifies for the premium reduction. www.regulations.gov will be posted to
payment, but is also used for claim The Social Security Administration will the docket unchanged. Because your
validation as well as for other legislated use this information to help determine comment will be made public, you are
functions such as quality monitoring, whether a beneficiary meets the solely responsible for ensuring that your
program integrity, and oversight. Form requirements for reduction of the Part A comment does not include any
mstockstill on DSK3G9T082PROD with NOTICES
Number: CMS–10174 (OMB control premium. Form Number: CMS–R–285 confidential information that you or a
number: 0938–0982); Frequency: (OMB control number: 0938–0769); third party may not wish to be posted,
Monthly; Affected Public: Business or Frequency: Once; Affected Public: State, such as medical information, your or
other for-profits and Not-for-profit Local, or Tribal Governments; Number anyone else’s Social Security number, or
institutions; Number of Respondents: of Respondents: 500; Total Annual confidential business information, such
779; Total Annual Responses: Responses: 500; Total Annual Hours: as a manufacturing process. Please note
1,409,828,464; Total Annual Hours: 125. (For policy questions regarding this that if you include your name, contact
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![14520 Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Notices
submit an annual report for devices FDA estimates the burden of this
distributed under the custom device collection of information as follows:
exemption.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Activity responses per annual burden per Total hours
respondents respondent responses response
Annual reporting for custom devices ................................... 33 1 33 40 1,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017. Dated: March 15, 2017. Health, 6701 Democracy Boulevard,
Leslie Kux, Melanie J. Pantoja, Suite 1000, Bethesda, Maryland 20892
Associate Commissioner for Policy. Program Analyst, Office of Federal Advisory (Mail code 4875), Telephone (301) 496–
[FR Doc. 2017–05349 Filed 3–20–17; 8:45 am]
Committee Policy. 2123, or spaethj@od.nih.gov.
[FR Doc. 2017–05487 Filed 3–20–17; 8:45 am] Dated: March 15, 2017.
BILLING CODE 4164–01–P
BILLING CODE 4140–01–P Jennifer S. Spaeth,
Director, Office of Federal Advisory
DEPARTMENT OF HEALTH AND Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES [FR Doc. 2017–05486 Filed 3–20–17; 8:45 am]
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
National Institutes of Health
National Institute of Mental Health; Eunice Kennedy Shrive National DEPARTMENT OF HEALTH AND
Notice of Closed Meeting Institute of Child Health and Human HUMAN SERVICES
Development; Notice of Committee
Pursuant to section 10(d) of the Establishment National Institutes of Health
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Pursuant to the Federal Advisory Notice of Diabetes Mellitus Interagency
hereby given of the following meeting. Committee Act, as amended (5 U.S.C. Coordinating Committee Meeting
App.), the Director, National Institutes SUMMARY: The Diabetes Mellitus
The meeting will be closed to the
of Health (NIH), announces the Interagency Coordinating Committee
public in accordance with the
establishment of the Task Force on (DMICC) will hold a meeting on April
provisions set forth in sections Research Specific to Pregnant Women
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 26–27, 2017. The topic for this meeting
and Lactating Women (Task Force) as will be ‘‘Opportunities for Research
as amended. The grant applications and required by section 2041 of the 21st
the discussions could disclose Supported by the Special Statutory
Century Cures Act, Public Law 114–255. Funding Program for Type 1 Diabetes
confidential trade secrets or commercial The Task Force will provide advice
property such as patentable material, Research.’’ The meeting is open to the
and guidance to the Secretary,
and personal information concerning public. Non-federal individuals
Department of Health and Human
planning to attend the workshop should
individuals associated with the grant Services (Secretary), regarding Federal
register by email to Charlemae Clarke,
applications, the disclosure of which activities related to identifying and
The Scientific Consulting Group, Inc.
would constitute a clearly unwarranted addressing gaps in knowledge and
(cclarke@scgcorp.com; please put
invasion of personal privacy. research regarding safe and effective
‘‘Registration DMICC T1D Meeting’’ in
therapies for pregnant women and
Name of Committee: National Institute of the subject line) at least 7 days prior to
lactating women, including the
Mental Health Special Emphasis Panel, the workshop.
Mental Health Services Research Conflicts. development of such therapies and the
DATES: The meeting will be held on
Date: April 7, 2017. collaboration on and coordination of
such activities. The Task Force will, not April 26, 2017 from 8:00 a.m. to 5:45
Time: 12:00 p.m. to 1:30 p.m. p.m. and on April 27, 2017 from 8:00
Agenda: To review and evaluate grant later than 18 months after the
establishment, prepare and submit a a.m. to 3:00 p.m.
applications.
report to the Secretary, the Committee ADDRESSES: The meeting will be held in
Place: National Institutes of Health,
on Health, Education, Labor and the Conference Room (terrace level) at
Neuroscience Center, 6001 Executive
Pensions of the Senate, and the 5635 Fishers Ln., Rockville, MD 20852.
Boulevard, Rockville, MD 20852 (Telephone
Conference Call). Committee on Energy and Commerce of FOR FURTHER INFORMATION CONTACT: An
Contact Person: Karen Gavin-Evans, Ph.D., the House of Representatives. agenda for the DMICC meeting will be
Scientific Review Officer, Division of It is determined that the Task Force is available by contacting Charlemae
Extramural Activities, National Institute of in the public interest in connection with Clarke, The Scientific Consulting Group,
the performance of duties imposed on Inc. (cclarke@scgcorp.com; please put
mstockstill on DSK3G9T082PROD with NOTICES
Mental Health, NIH Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC the NIH by statute, and that these duties ‘‘Agenda Request for DMICC T1D
9606, Bethesda, MD 20892, 301–451–2356, can best be performed through the Meeting’’ in the subject line). For further
gavinevanskm@mail.nih.gov. advice and counsel of this group. information concerning this meeting,
(Catalogue of Federal Domestic Assistance Inquiries may be directed to Jennifer contact Dr. B. Tibor Roberts, Executive
Program No. 93.242, Mental Health Research Spaeth, Director, Office of Federal Secretary of the Diabetes Mellitus
Grants, National Institutes of Health, HHS) Advisory Committee Policy, Office of Interagency Coordinating Committee,
the Director, National Institutes of National Institute of Diabetes and
VerDate Sep<11>2014 16:47 Mar 20, 2017 Jkt 241001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\21MRN1.SGM 21MRN1](https://thefederalregister.org/doc/82_FR_14571/page/3.svg)
Document Created: 2017-03-21 01:09:56
Document Modified: 2017-03-21 01:09:56
| 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 May 22, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 14518 |
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