81 FR 91181 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 242 (December 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 242 (December 16, 2016)
| Page Range | 91181-91183 | |
| FR Document | 2016-30243 |
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)] [Notices] [Pages 91181-91183] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30243] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3995] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure 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 (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 requirement for submission of information on pediatric subpopulations [[Page 91182]] that suffer from a disease or condition that a device is intended to treat, diagnose, or cure. DATES: Submit either electronic or written comments on the collection of information by February 14, 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 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-2016-N-3995 for ``Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure.'' 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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 Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure--21 CFR Part 814--OMB Control Number 0910-0748--Extension Section 515A(a) of the FD&C Act requires applicants who submit certain medical device applications to include readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. The information submitted will allow FDA to track the number of approved devices for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure and the review time for each such device application. These requirements apply to applicants who submit humanitarian device exemption requests (HDEs), premarket approval applications (PMAs) or PMA supplements, or a product development protocol (PDP). FDA expects to receive approximately 45 original PMA/PDP/HDE applications [[Page 91183]] each year, 5 of which FDA expects to be HDEs. This estimate is based on the average of FDA's receipt of new PMA applications. The Agency estimates that 10 of the estimated 40 original PMA submissions will fail to provide the required pediatric use information and their sponsors will therefore be required to submit PMA amendments. The Agency also expects to receive approximately 700 supplements that will include the pediatric use information required by section 515A(a) of the FD&C Act and part 814 (21 CFR part 814). All that is required is to gather, organize, and submit information that is readily available, using any approach that meets the requirements of section 515A(a) of the FD&C Act and part 814. We believe that because the applicant is required to organize and submit only readily available information, no more than 8 hours will be required to comply. Furthermore, because supplements may include readily available information on pediatric populations by referencing a previous submission, FDA estimates the average time to obtain and submit the required information in a supplement to be 2 hours. FDA estimates that the total estimated burden is 1,760 hours. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Number of Average Activity/21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Pediatric information in an original PMA 30 1 30 8 240 or PDP--814.20(b)(13)................... Pediatric information in a PMA amendment-- 10 1 10 8 80 814.37(b)(2)............................ Pediatric information in a PMA 700 1 700 2 1,400 supplement--814.39(c)(2)................ Pediatric information in an HDE-- 5 1 5 8 40 814.104(b)(6)........................... ---------------------------------------------------------------------- Total................................ ............ .............. ............ ............ 1,760 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30243 Filed 12-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91181
Submissions,’’ publicly viewable at Analysis, Food and Drug the Agency and the statutory safeguards
https://www.regulations.gov or at the Administration, Bldg. 32, Rm. 4238, in 21 U.S.C. 379dd. In addition, the
Division of Dockets Management 10903 New Hampshire Ave., Silver discussion of restrictions on funds for
between 9 a.m. and 4 p.m., Monday Spring, MD, 20993, 301–796–8828, travel has been clarified to better reflect
through Friday. robert.berlin@fda.hhs.gov. Alternate the scope of statutes and policies
• Confidential Submissions—To contact: Office of Policy, 301–796–4830. governing the use of non-Agency funds
submit a comment with confidential SUPPLEMENTARY INFORMATION: for travel.
information that you do not wish to be This guidance is being issued
made publicly available, submit your I. Background consistent with FDA’s good guidance
comments only as a written/paper FDA is announcing the availability of practices regulation (21 CFR 10.115).
submission. You should submit two a guidance for the public and FDA staff The guidance represents the current
copies total. One copy will include the entitled ‘‘Gifts to FDA: Evaluation and thinking of FDA on this matter. It does
information you claim to be confidential Acceptance.’’ The Secretary of HHS has not establish any rights for any person
with a heading or cover note that states the authority to accept conditional or and is not binding on FDA or the public.
‘‘THIS DOCUMENT CONTAINS unconditional gifts on behalf of the You can use an alternative approach if
CONFIDENTIAL INFORMATION.’’ The United States. The Secretary has it satisfies the requirements of the
Agency will review this copy, including delegated this gift authority to the applicable statutes and regulations.
the claimed confidential information, in Commissioner of Food and Drugs. This
II. Electronic Access
its consideration of comments. The guidance provides the process and
second copy, which will have the principles we will use in implementing Persons with access to the Internet
claimed confidential information this authority. may obtain the guidance at either http://
redacted/blacked out, will be available FDA will consider gifts from all www.fda.gov/RegulatoryInformation/
for public viewing and posted on sources except the Reagan-Udall Guidances/default.htm or https://
https://www.regulations.gov. Submit Foundation (RUF) on a case-by-case www.regulations.gov.
both copies to the Division of Dockets basis using a balancing test, described in Dated: December 13, 2016.
Management. If you do not wish your the guidance. While any person may Leslie Kux,
name and contact information to be offer a gift, there are five reasons we Associate Commissioner for Policy.
made publicly available, you can should reject a gift without additional
[FR Doc. 2016–30312 Filed 12–15–16; 8:45 am]
provide this information on the cover evaluation. We should not accept a gift
BILLING CODE 4164–01–P
sheet and not in the body of your if: (1) The donor imposes conditions
comments and you must identify this that are illegal, are contrary to public
information as ‘‘confidential.’’ Any policy, are unreasonable to administer, DEPARTMENT OF HEALTH AND
information marked as ‘‘confidential’’ are contrary to FDA’s current policies HUMAN SERVICES
will not be disclosed except in and procedures, or are contrary to
accordance with 21 CFR 10.20 and other generally accepted public standards; (2) Food and Drug Administration
applicable disclosure law. For more the donor requires us to provide the
donor with some privilege, concession, [Docket No. FDA–2016–N–3995]
information about FDA’s posting of
comments to public dockets, see 80 FR or other present or future benefit in Agency Information Collection
56469, September 18, 2015, or access return for the gift; (3) a debarred entity Activities; Proposed Collection;
the information at: http://www.fda.gov/ offers the gift; (4) a different authority or Comment Request; Medical Devices;
financial mechanism applies; or (5) the
regulatoryinformation/dockets/ Pediatric Uses of Devices;
total costs associated with acceptance
default.htm. Requirement for Submission of
Docket: For access to the docket to are expected to exceed the cost of
Information on Pediatric
read background documents or the purchasing a similar item and the cost
Subpopulations That Suffer From a
electronic and written/paper comments of normal care and maintenance.
In the Federal Register of June 29, Disease or Condition That a Device Is
received, go to https:// Intended To Treat, Diagnose, or Cure
2016 (81 FR 42365), FDA announced the
www.regulations.gov and insert the
availability of a draft guidance entitled AGENCY: Food and Drug Administration,
docket number, found in brackets in the ‘‘Gifts to FDA: Evaluation and
heading of this document, into the HHS.
Acceptance: Evaluation and ACTION: Notice.
‘‘Search’’ box and follow the prompts Acceptance.’’ FDA received one
and/or go to the Division of Dockets comment expressing concern regarding SUMMARY: The Food and Drug
Management, 5630 Fishers Lane, Rm. the policy described in the guidance. It Administration (FDA or Agency) is
1061, Rockville, MD 20852. appears the commenter may have announcing an opportunity for public
Submit written requests for single misunderstood the policy and comment on the proposed collection of
copies of this guidance to the Office of incorrectly believed that gifts would not certain information by the Agency.
Policy, Office of Policy, Planning, be limited, would be unreported, and Under the Paperwork Reduction Act of
Legislation, and Analysis, Food and would be provided to Federal 1995 (the PRA), Federal Agencies are
Drug Administration, Bldg. 32, Rm. employees themselves. As explained in required to publish notice in the
4238, 10903 New Hampshire Ave., the guidance, that is not the case. Federal Register concerning each
Silver Spring, MD, 20993. Send one self- Rather, the recipients of any gifts would proposed collection of information,
addressed adhesive label to assist that be the Agency, gifts are extensively including each proposed extension of an
mstockstill on DSK3G9T082PROD with NOTICES
office in processing your requests. See reviewed to ensure receipt would be existing collection of information, and
the SUPPLEMENTARY INFORMATION section appropriate, and the Agency intends to to allow 60 days for public comment in
for electronic access to the guidance publish a summary of received gifts. response to the notice. This notice
document. The Agency has made only minor solicits comments on information
FOR FURTHER INFORMATION CONTACT: changes to the guidance to clarify that collection associated with the
Robert Berlin, Office of Policy, Office of the evaluation of gifts from RUF will requirement for submission of
Policy, Planning, Legislation, and reflect RUF’s unique role in support of information on pediatric subpopulations
VerDate Sep<11>2014 18:42 Dec 15, 2016 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\16DEN1.SGM 16DEN1](https://thefederalregister.org/doc/81_FR_91423/page/1.svg)
![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91183
each year, 5 of which FDA expects to be information required by section 515A(a) Furthermore, because supplements may
HDEs. This estimate is based on the of the FD&C Act and part 814 (21 CFR include readily available information on
average of FDA’s receipt of new PMA part 814). pediatric populations by referencing a
applications. The Agency estimates that All that is required is to gather, previous submission, FDA estimates the
10 of the estimated 40 original PMA organize, and submit information that is average time to obtain and submit the
submissions will fail to provide the readily available, using any approach required information in a supplement to
required pediatric use information and that meets the requirements of section be 2 hours. FDA estimates that the total
their sponsors will therefore be required 515A(a) of the FD&C Act and part 814. estimated burden is 1,760 hours.
to submit PMA amendments. The We believe that because the applicant is
Agency also expects to receive required to organize and submit only FDA estimates the burden of this
approximately 700 supplements that readily available information, no more collection of information as follows:
will include the pediatric use than 8 hours will be required to comply.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Pediatric information in an original PMA or PDP—814.20(b)(13) 30 1 30 8 240
Pediatric information in a PMA amendment—814.37(b)(2) .......... 10 1 10 8 80
Pediatric information in a PMA supplement—814.39(c)(2) ........... 700 1 700 2 1,400
Pediatric information in an HDE—814.104(b)(6) ........................... 5 1 5 8 40
Total ........................................................................................ ...................... ........................ ...................... ...................... 1,760
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 12, 2016. Dated: December 12, 2016. constitute a clearly unwarranted
Leslie Kux, Lawrence A. Tabak, invasion of personal privacy.
Associate Commissioner for Policy. Deputy Director, National Institutes of Health. Name of Committee: National Advisory
[FR Doc. 2016–30243 Filed 12–15–16; 8:45 am] [FR Doc. 2016–30398 Filed 12–15–16; 8:45 am] Council on Alcohol Abuse and Alcoholism.
BILLING CODE 4140–01–P Date: February 9, 2017.
BILLING CODE 4164–01–P
Closed: 9:00 a.m. to 9:30 a.m.
Agenda: BSC Report: Evaluation of the
DEPARTMENT OF HEALTH AND NIAAA Intramural Program.
DEPARTMENT OF HEALTH AND Place: National Institutes of Health,
HUMAN SERVICES HUMAN SERVICES
National Institute on Alcohol Abuse and
National Institutes of Health Alcoholism, 5635 Fishers Lane, Terrace
National Institutes of Health Conference Rooms, Bethesda, MD 20892.
National Institute on Alcohol Abuse Closed: 9:40 a.m. to 10:50 a.m.
Extension of Effective Date of NIH Agenda: To review and evaluate grant
and Alcoholism; Notice of Meeting
Policy on the Use of a Single applications.
Institutional Review Board for Multi- Pursuant to section 10(d) of the Place: National Institutes of Health,
Site Research Federal Advisory Committee Act, as National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
amended (5 U.S.C. App.), notice is Conference Rooms, Bethesda, MD 20892.
The National Institutes of Health hereby given of a meeting of the Open: 11:00 a.m. to 3:15 p.m.
(NIH) is extending the effective date of National Advisory Council on Alcohol Agenda: Presentations and other business
the NIH Policy on the Use of a Single Abuse and Alcoholism. of the Council.
Institutional Review Board for Multi- The meeting will be open to the Place: National Institutes of Health,
Site Research from May 25, 2017, to public as indicated below, with National Institute on Alcohol Abuse and
September 25, 2017. A copy of the NIH attendance limited to space available. Alcoholism, 5635 Fishers Lane, Terrace
Policy was published in the Federal Individuals who plan to attend and Conference Rooms, Bethesda, MD 20892.
need special assistance, such as sign Contact Person: Abraham P. Bautista,
Register on June 21, 2016 (81 FR 40325).
Ph.D., Executive Secretary, National Institute
See https://www.gpo.gov/fdsys/pkg/FR- language interpretation or other on Alcohol Abuse and Alcoholism, National
2016-06-21/pdf/2016-14513.pdf. reasonable accommodations, should Institutes of Health, 5635 Fishers Lane, Room
Guidance and Frequently Asked notify the Contact Person listed below 2085, Rockville, MD 20852, 301–443–9737
Questions to assist in the in advance of the meeting. bautista@mail.nih.gov.
implementation of the policy will soon The meeting will be closed to the Any interested person may file written
be available at http://osp.od.nih.gov/ public in accordance with the comments with the committee by forwarding
office-clinical-research-and-bioethics- provisions set forth in sections the statement to the Contact Person listed on
policy/clinical-research-policy/models- 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., this notice. The statement should include the
as amended. The grant applications and name, address, telephone number and when
mstockstill on DSK3G9T082PROD with NOTICES
irb-review. applicable, the business or professional
the discussions could disclose
For further information contact the confidential trade secrets or commercial affiliation of the interested person.
NIH Office of Science Policy, Information is also available on the
property such as patentable material, Institute’s/Center’s home page: http://
Telephone: 301–496–9838, Email: and personal information concerning www.niaaa.nih.gov/AboutNIAAA/
SingleIRBPolicy@mail.nih.gov. individuals associated with the grant AdvisoryCouncil/Pages/default.aspx, where
applications and/or contract proposals, an agenda and any additional information for
the disclosure of which would the meeting will be posted when available.
VerDate Sep<11>2014 18:42 Dec 15, 2016 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\16DEN1.SGM 16DEN1](https://thefederalregister.org/doc/81_FR_91423/page/3.svg)
Document Created: 2018-02-14 09:07:24
Document Modified: 2018-02-14 09:07:24
| 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 February 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 91181 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR