82 FR 14224 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 51 (March 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 51 (March 17, 2017)
| Page Range | 14224-14225 | |
| FR Document | 2017-05302 |
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)] [Notices] [Pages 14224-14225] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05302] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0117] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices 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 April 17, 2017. 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 0910-0762. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [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. Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910-0762--Extension The guidance document entitled ``Providing Information About Pediatric Uses of Medical Devices--Guidance for Industry and Food and Drug Administration Staff'' suggests that applicants who submit certain medical device applications include, if readily available, pediatric use information for diseases or conditions that the device is being used to treat, diagnose, or cure that are outside the device's approved or proposed indications for use, as well as an estimate of the number of pediatric patients with such diseases or conditions. The information submitted will allow FDA to identify pediatric uses of devices outside their approved or proposed indication for use to determine areas where further pediatric device development could be useful. This recommendation applies to applicants who submit the following applications: (1) Any request for a humanitarian device exemption submitted under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)); (2) any premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FD&C Act (21 U.S.C. 360e); and (3) any product development protocol submitted under section 515 of the FD&C Act. Respondents are permitted to submit information relating to uses of the device outside the approved or proposed indication if such uses are described or acknowledged in acceptable sources of readily available information. We estimate that 20 percent of respondents submitting information required by section 515A of the FD&C Act will choose to submit this information and that it will take 30 minutes for them to do so. In the Federal Register of December 5, 2016 (81 FR 87575), 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: [[Page 14225]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Description Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Uses outside approved indication............. 148 1 148 0.5 (30 minutes)..................... 74 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. 2017-05302 Filed 3-16-17; 8:45 am] BILLING CODE 4164-01-P
![14224 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
submitter may request status reports and fax it to the Center for Devices and comment on the proposed collection of
every 30 days following the initial status Radiological Health office identified on information. No comments were
request. To obtain a 510(k) status report, the form. received.
the submitter should complete the In the Federal Register of November
FDA estimates the burden of this
status request form, Form FDA 3541, 18, 2016 (81 FR 81772), FDA published
collection of information as follows:
a 60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity and 21 CFR part/section Form FDA No. responses per burden per Total hours
respondents responses
respondent response
510(k) submission (807 subpart E) ...... ........................ 3,900 1 3,900 79 ..................... 308,100
Summary cover sheet (807.87) ............ 3514 1,956 1 1,956 .5 (30 minutes) 978
Status request (807.90(a)(3)) ............... 3541 218 1 218 .25 (15 minutes) 55
Standards (807.87(d) and (f)) ............... 3654 2,700 1 2,700 10 ..................... 27,000
510(k) statement (807.93) .................... ........................ 225 10 2,250 10 ..................... 22,500
Total ............................................... ........................ ........................ ........................ ........................ ........................... 358,633
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017. 202–395–7285, or emailed to oira_ conditions. The information submitted
Leslie Kux, submission@omb.eop.gov. All will allow FDA to identify pediatric
Associate Commissioner for Policy. comments should be identified with the uses of devices outside their approved
[FR Doc. 2017–05300 Filed 3–16–17; 8:45 am] OMB control number 0910–0762. Also or proposed indication for use to
BILLING CODE 4164–01–P
include the FDA docket number found determine areas where further pediatric
in brackets in the heading of this device development could be useful.
document. This recommendation applies to
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA applicants who submit the following
HUMAN SERVICES PRA Staff, Office of Operations, Food applications: (1) Any request for a
and Drug Administration, Three White humanitarian device exemption
Food and Drug Administration submitted under section 520(m) of the
Flint North 10A–12M, 11601
[Docket No. FDA–2013–D–0117] Landsdown St., North Bethesda, MD Federal Food, Drug, and Cosmetic Act
20852, PRAStaff@fda.hhs.gov. (the FD&C Act) (21 U.S.C. 360j(m)); (2)
Agency Information Collection any premarket approval application
SUPPLEMENTARY INFORMATION: In
Activities; Submission for Office of (PMA) or supplement to a PMA
compliance with 44 U.S.C. 3507, FDA submitted under section 515 of the
Management and Budget Review; has submitted the following proposed
Comment Request; Providing FD&C Act (21 U.S.C. 360e); and (3) any
collection of information to OMB for product development protocol
Information About Pediatric Uses of review and clearance.
Medical Devices submitted under section 515 of the
Providing Information About Pediatric FD&C Act.
AGENCY: Food and Drug Administration, Uses of Medical Devices Under Section Respondents are permitted to submit
HHS. 515A of the Federal Food, Drug, and information relating to uses of the
ACTION: Notice. Cosmetic Act device outside the approved or
proposed indication if such uses are
SUMMARY: The Food and Drug OMB Control Number 0910–0762— described or acknowledged in
Administration (FDA) is announcing Extension acceptable sources of readily available
that a proposed collection of
The guidance document entitled information. We estimate that 20
information has been submitted to the
‘‘Providing Information About Pediatric percent of respondents submitting
Office of Management and Budget
Uses of Medical Devices—Guidance for information required by section 515A of
(OMB) for review and clearance under
Industry and Food and Drug the FD&C Act will choose to submit this
the Paperwork Reduction Act of 1995.
Administration Staff’’ suggests that information and that it will take 30
DATES: Fax written comments on the applicants who submit certain medical minutes for them to do so.
collection of information by April 17, device applications include, if readily In the Federal Register of December 5,
2017. available, pediatric use information for 2016 (81 FR 87575), FDA published a
ADDRESSES: To ensure that comments on diseases or conditions that the device is 60-day notice requesting public
the information collection are received, being used to treat, diagnose, or cure comment on the proposed collection of
OMB recommends that written that are outside the device’s approved or information. No comments were
comments be faxed to the Office of proposed indications for use, as well as received.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Information and Regulatory Affairs, an estimate of the number of pediatric FDA estimates the burden of this
OMB, Attn: FDA Desk Officer, FAX: patients with such diseases or collection of information as follows:
VerDate Sep<11>2014 20:02 Mar 16, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1](https://thefederalregister.org/doc/82_FR_14275/page/1.svg)
![Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices 14225
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Description responses per Total hours
respondents responses per response
respondent
Uses outside approved indication ..................................... 148 1 148 0.5 (30 minutes) 74
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017. by telephone at (301) 443–0445 or by Center Drive, Building 31, Conference
Leslie Kux, email at acohen@hrsa.gov. Room 10, Bethesda, MD, 20892 which
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: was published in the Federal Register
[FR Doc. 2017–05302 Filed 3–16–17; 8:45 am] NACRHHS provides counsel and on March 3, 2017, 82 FR 12459.
BILLING CODE 4164–01–P recommendations to the Secretary with The meeting notice is amended to
respect to the delivery, research, change the meeting start and end time
development, and administration of to 9:00 a.m. to 4:30 p.m. The date and
DEPARTMENT OF HEALTH AND health and human services in rural location remain the same. The meeting
HUMAN SERVICES areas. is open to the public.
The meeting on Monday, April 10, Dated: March 14, 2017.
Health Resources and Services will be called to order at 9:00 a.m. by Melanie J. Pantoja,
Administration the Chairperson of the Committee, the Program Analyst, Office of Federal Advisory
Honorable Ronnie Musgrove. The Committee Policy.
National Advisory Committee on Rural Committee will examine the current [FR Doc. 2017–05391 Filed 3–16–17; 8:45 am]
Health and Human Services delivery of health care and human BILLING CODE 4140–01–P
AGENCY: Health Resources and Services services in rural areas. The day will
Administration (HRSA), Department of conclude with a period of public
Health and Human Services. comment at approximately 5:00 p.m. DEPARTMENT OF HEALTH AND
The Committee will visit the Hubert HUMAN SERVICES
ACTION: Notice of meeting.
H. Humphrey Building on Tuesday,
SUMMARY: In accordance with the April 11. The day will conclude with a National Institutes of Health
Federal Advisory Committee Act, notice period of public comment at
is hereby given that a meeting is approximately 5:00 p.m. National Human Genome Research
scheduled for the National Advisory The Committee will meet to Institute; Notice of Closed Meeting
Committee on Rural Health and Human summarize key findings and develop a
Pursuant to section 10(d) of the
Services (NACRHHS). This meeting will work plan for the next quarter and its
Federal Advisory Committee Act, as
be open to the public. Information about future meeting on Wednesday, April 12,
amended (5 U.S.C. App.), notice is
NACRHHS and the agenda for this at 9:00 a.m., at the Hyatt Place Hotel.
hereby given of the following meeting.
meeting can be obtained by accessing The Hubert H. Humphrey Building The meeting will be closed to the
the following Web site: http:// requires a security screening on entry. public in accordance with the
www.hrsa.gov/advisorycommittees/ To facilitate your access to the building, provisions set forth in sections
rural. please contact Adam Cohen before April 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
7, 2017 at (301) 443–0445. Individuals as amended. The grant applications and
DATES: who plan to attend and need special
April 10, 2017, 9:00 a.m.–5:00 p.m. EDT the discussions could disclose
assistance, such as sign language confidential trade secrets or commercial
April 11, 2017, 8:30 a.m.–5:00 p.m. EDT
April 12, 2017, 9:00 a.m.–11:00 a.m. interpretation or other reasonable property such as patentable material,
EDT accommodations, should notify Adam and personal information concerning
Cohen by telephone at (301) 443–0445 individuals associated with the grant
ADDRESSES: This meeting will be held or by email at acohen@hrsa.gov at least
in-person at the Hyatt Place Hotel. The applications, the disclosure of which
10 days prior to the meeting. would constitute a clearly unwarranted
address for the meeting is 400 E Street
SW., Washington, DC 20024. The Jason E. Bennett, invasion of personal privacy.
meeting will also be held in-person at Director, Division of the Executive Secretariat. Name of Committee: National Human
the Hubert H. Humphrey Building, [FR Doc. 2017–05298 Filed 3–16–17; 8:45 am] Genome Research Institute Special Emphasis
Panel; Gabriella Miller Kids First.
located at 200 Independence Avenue BILLING CODE 4165–15–P
Date: April 24, 2017.
SW., Washington, DC, on April 11. Time: 8:00 a.m. to 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: Agenda: To review and evaluate grant
Steve Hirsch, Administrative DEPARTMENT OF HEALTH AND applications.
Coordinator, NACRHHS, HRSA, 5600 HUMAN SERVICES Place: Westin Grand Thomas Boardroom,
Fishers Lane, Room 17W41C, Rockville, 2350 M Street NW., Washington, DC 20037.
Maryland 20857, telephone (301) 443– National Institutes of Health Contact Person: Barbara J. Thomas, Ph.D.,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Scientific Review Officer Scientific Review
0835, fax (301) 443–2803 or by email at National Cancer Institute; Amended Branch, National Human Genome Research
shirsch@hrsa.gov. Notice of Meeting Institute, National Institutes of Health, 5635
Persons interested in attending any Fishers Lane, Ste. 4076, MSC 9306, Bethesda,
portion of the meeting, including the Notice is hereby given of a change in MD 20892–9306, 301–402–0838,
April 11 portion at the Hubert H. the meeting of the National Cancer barbara.thomas@nih.gov.
Humphrey Building, should contact Institute Board of Scientific Advisors, (Catalogue of Federal Domestic Assistance
Adam Cohen at the Federal Office of March 21, 2017, 08:30 a.m. to 05:00 Program Nos. 93.172, Human Genome
Rural Health Policy before April 7, 2017 p.m., National Institutes of Health, 31 Research, National Institutes of Health, HHS)
VerDate Sep<11>2014 20:02 Mar 16, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1](https://thefederalregister.org/doc/82_FR_14275/page/2.svg)
Document Created: 2017-03-17 02:49:14
Document Modified: 2017-03-17 02:49:14
| 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 | Fax written comments on the collection of information by April 17, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 14224 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR