82 FR 24716 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 102 (May 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 102 (May 30, 2017)
| Page Range | 24716-24717 | |
| FR Document | 2017-10982 |
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)] [Notices] [Pages 24716-24717] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10982] [[Page 24716]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1095] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health 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 voluntarily submitted to the Center for Devices and Radiological Health (CDRH) on actual or potential health risk concerns about a medical device or radiological product or its use. DATES: Submit either electronic or written comments on the collection of information by July 31, 2017. 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 July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2017. 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''). 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-1095 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health.'' 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 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.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: 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 [[Page 24717]] 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. Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health OMB Control Number 0910-0769--Extension This information collection request collects information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device or radiological product or its use. Because, prior to the establishment of the electronic submission process for voluntary allegations to CDRH, there had been no established guidelines or instructions on how to submit an allegation to CDRH, allegations often contained minimal information and were received via phone calls, emails, or conversationally. CDRH has established a consistent format and process for the submission of device allegations that enhances our timeliness in receiving, assessing, and evaluating voluntary allegations. The information provided in the allegations received by CDRH may be used to clarify the recurrence or emergence of significant device-related risks to the general public and the need to initiate educational outreach or regulatory action to minimize or mitigate identified risks. 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 ---------------------------------------------------------------------------------------------------------------- Electronic submission of 700 1 700 .25 (15 minutes) 175 voluntary allegations to CDRH. ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-10982 Filed 5-26-17; 8:45 am] BILLING CODE 4164-01-P
![24716 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
DEPARTMENT OF HEALTH AND include any confidential information redacted/blacked out, will be available
HUMAN SERVICES that you or a third party may not wish for public viewing and posted on
to be posted, such as medical https://www.regulations.gov/. Submit
Food and Drug Administration information, your or anyone else’s both copies to the Division of Dockets
[Docket No. FDA–2017–N–1095] Social Security number, or confidential Management. If you do not wish your
business information, such as a name and contact information to be
Agency Information Collection manufacturing process. Please note that made publicly available, you can
Activities; Proposed Collection; if you include your name, contact provide this information on the cover
Comment Request; Electronic information, or other information that sheet and not in the body of your
Submission Process for Voluntary identifies you in the body of your comments and you must identify this
Allegations to the Center for Devices comments, that information will be information as ‘‘confidential.’’ Any
and Radiological Health posted on https://www.regulations.gov/. information marked as ‘‘confidential’’
• If you want to submit a comment will not be disclosed except in
AGENCY: Food and Drug Administration, with confidential information that you accordance with 21 CFR 10.20 and other
HHS. do not wish to be made available to the applicable disclosure law. For more
ACTION: Notice. public, submit the comment as a information about FDA’s posting of
written/paper submission and in the comments to public dockets, see 80 FR
SUMMARY: The Food and Drug
manner detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access
Administration (FDA or Agency) is
Submissions’’ and ‘‘Instructions’’). the information at: https://www.fda.gov/
announcing an opportunity for public
comment on the proposed collection of Written/Paper Submissions regulatoryinformation/dockets/
certain information by the Agency. default.htm.
Submit written/paper submissions as Docket: For access to the docket to
Under the Paperwork Reduction Act of follows: read background documents or the
1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for electronic and written/paper comments
required to publish notice in the written/paper submissions): Division of
Federal Register concerning each received, go to https://
Dockets Management (HFA–305), Food www.regulations.gov/ and insert the
proposed collection of information, and Drug Administration, 5630 Fishers
including each proposed extension of an docket number, found in brackets in the
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
existing collection of information, and • For written/paper comments
to allow 60 days for public comment in ‘‘Search’’ box and follow the prompts
submitted to the Division of Dockets
response to the notice. This notice and/or go to the Division of Dockets
Management, FDA will post your
solicits comments on information Management, 5630 Fishers Lane, Rm.
comment, as well as any attachments,
voluntarily submitted to the Center for 1061, Rockville, MD 20852.
except for information submitted,
Devices and Radiological Health (CDRH) FOR FURTHER INFORMATION CONTACT:
marked and identified, as confidential,
on actual or potential health risk if submitted as detailed in JonnaLynn Capezzuto, Office of
concerns about a medical device or ‘‘Instructions.’’ Operations, Food and Drug
radiological product or its use. Instructions: All submissions received Administration, Three White Flint
DATES: Submit either electronic or must include the Docket No. FDA– North, 10A63, 11601 Landsdown St.,
written comments on the collection of 2017–N–1095 for ‘‘Agency Information North Bethesda, MD 20852, 301–796–
information by July 31, 2017. Collection Activities; Proposed 3794.
ADDRESSES: You may submit comments Collection; Comment Request; SUPPLEMENTARY INFORMATION: Under the
as follows. Please note that late, Electronic Submission Process for PRA (44 U.S.C. 3501–3520), Federal
untimely filed comments will not be Voluntary Allegations to the Center for Agencies must obtain approval from the
considered. Electronic comments must Devices and Radiological Health.’’ Office of Management and Budget
be submitted on or before July 31, 2017. Received comments, those filed in a (OMB) for each collection of
The https://www.regulations.gov timely manner (see ADDRESSES), will be information they conduct or sponsor.
electronic filing system will accept placed in the docket and, except for ‘‘Collection of information’’ is defined
comments until midnight Eastern Time those submitted as ‘‘Confidential in 44 U.S.C. 3502(3) and 5 CFR
at the end of July 31, 2017. Comments Submissions,’’ publicly viewable at 1320.3(c) and includes Agency requests
received by mail/hand delivery/courier https://www.regulations.gov/ or at the or requirements that members of the
(for written/paper submissions) will be Division of Dockets Management public submit reports, keep records, or
considered timely if they are between 9 a.m. and 4 p.m., Monday provide information to a third party.
postmarked or the delivery service through Friday. Section 3506(c)(2)(A) of the PRA (44
acceptance receipt is on or before that • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal
date. submit a comment with confidential Agencies to provide a 60-day notice in
information that you do not wish to be the Federal Register concerning each
Electronic Submissions made publicly available, submit your proposed collection of information,
Submit electronic comments in the comments only as a written/paper including each proposed extension of an
following way: submission. You should submit two existing collection of information,
• Federal eRulemaking Portal: copies total. One copy will include the before submitting the collection to OMB
https://www.regulations.gov/. Follow information you claim to be confidential for approval. To comply with this
the instructions for submitting with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
requirement, FDA is publishing notice
comments. Comments submitted ‘‘THIS DOCUMENT CONTAINS of the proposed collection of
electronically, including attachments, to CONFIDENTIAL INFORMATION.’’ The information set forth in this document.
https://www.regulations.gov/ will be Agency will review this copy, including With respect to the following
posted to the docket unchanged. the claimed confidential information, in collection of information, FDA invites
Because your comment will be made its consideration of comments. The comments on these topics: (1) Whether
public, you are solely responsible for second copy, which will have the the proposed collection of information
ensuring that your comment does not claimed confidential information is necessary for the proper performance
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![Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 24717
of FDA’s functions, including whether Electronic Submission Process for information and were received via
the information will have practical Voluntary Allegations to the Center for phone calls, emails, or conversationally.
utility; (2) the accuracy of FDA’s Devices and Radiological Health CDRH has established a consistent
estimate of the burden of the proposed OMB Control Number 0910–0769— format and process for the submission of
collection of information, including the Extension device allegations that enhances our
validity of the methodology and timeliness in receiving, assessing, and
This information collection request evaluating voluntary allegations. The
assumptions used; (3) ways to enhance
collects information voluntarily information provided in the allegations
the quality, utility, and clarity of the
submitted to CDRH on actual or received by CDRH may be used to
information to be collected; and (4) potential health risk concerns about a
ways to minimize the burden of the clarify the recurrence or emergence of
medical device or radiological product
collection of information on significant device-related risks to the
or its use. Because, prior to the
respondents, including through the use general public and the need to initiate
establishment of the electronic
of automated collection techniques, submission process for voluntary educational outreach or regulatory
when appropriate, and other forms of allegations to CDRH, there had been no action to minimize or mitigate identified
information technology. established guidelines or instructions on risks.
how to submit an allegation to CDRH, FDA estimates the burden of this
allegations often contained minimal collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual
Activity responses per Average burden per response Total hours
respondents responses
respondent
Electronic submission of voluntary 700 1 700 .25 (15 minutes) ............................... 175
allegations to CDRH.
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 23, 2017. Cast and will be available at the Agenda: On July 28, 2017, the
Anna K. Abram, following link: https:// VRBPAC will meet in an open session
Deputy Commissioner for Policy, Planning, collaboration.fda.gov/vrbpac072817/. to discuss and make recommendations
Legislation, and Analysis. Answers to commonly asked questions on the safety and efficacy of a Hepatitis
[FR Doc. 2017–10982 Filed 5–26–17; 8:45 am] including information regarding special B Vaccine manufactured by Dynavax.
BILLING CODE 4164–01–P accommodations due to a disability, FDA intends to make background
visitor parking, and transportation may material available to the public no later
be accessed at: http://www.fda.gov/ than 2 business days before the meeting.
DEPARTMENT OF HEALTH AND AdvisoryCommittees/AboutAdvisory If FDA is unable to post the background
HUMAN SERVICES Committees/ucm408555.htm. material on its Web site prior to the
meeting, the background material will
Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
be made publicly available at the
CAPT Serina Hunter-Thomas or
[Docket No. FDA–2017–N–0001] location of the advisory committee
Rosanna Harvey, Center for Biologics meeting, and the background material
Vaccines and Related Biological Evaluation and Research, Food and will be posted on FDA’s Web site after
Products Advisory Committee; Notice Drug Administration, 10903 New the meeting. Background material is
of Meeting Hampshire Ave., Bldg. 71, Rm. 6307C, available at http://www.fda.gov/
Silver Spring, MD 20993–0002, at 240– AdvisoryCommittees/Calendar/
AGENCY: Food and Drug Administration, 402–5771 serina.hunter-thomas@
HHS. default.htm. Scroll down to the
fda.hhs.gov and 240–402–8072, appropriate advisory committee meeting
ACTION: Notice. rosanna.harvey@fda.hhs.gov, or FDA link.
Advisory Committee Information Line,
SUMMARY: The Food and Drug Procedure: Interested persons may
1–800–741–8138 (301–443–0572 in the
Administration (FDA) announces a present data, information, or views,
Washington, DC area). A notice in the
forthcoming public advisory committee orally or in writing, on issues pending
Federal Register about last minute
meeting of the Vaccines and Related before the committee. Written
modifications that impact a previously
Biological Products Advisory submissions may be made to the contact
announced advisory committee meeting
Committee (VRBPAC). The general person on or before July 21, 2017. Oral
cannot always be published quickly
function of the committee is to provide presentations from the public will be
enough to provide timely notice.
advice and recommendations to the scheduled between approximately 1:15
Therefore, you should always check the
Agency on FDA’s regulatory issues. The p.m. and 2:15 p.m. Those individuals
Agency’s Web site at http://
meeting will be open to the public. interested in making formal oral
www.fda.gov/AdvisoryCommittees/
DATES: The meeting will be held on July presentations should notify the contact
sradovich on DSK3GMQ082PROD with NOTICES
default.htm and scroll down to the
28, 2017, from 8:30 a.m. to 5 p.m. appropriate advisory committee meeting person and submit a brief statement of
ADDRESSES: FDA White Oak Campus, link, or call the advisory committee the general nature of the evidence or
10903 New Hampshire Ave., Building information line to learn about possible arguments they wish to present, the
31 Conference Center, the Great Room modifications before coming to the names and addresses of proposed
(Rm. 1503), Silver Spring, MD 20993– meeting. participants, and an indication of the
0002. For those unable to attend in approximate time requested to make
person, the meeting will also be Web SUPPLEMENTARY INFORMATION: their presentation on or before July 13,
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Document Created: 2018-11-08 08:55:07
Document Modified: 2018-11-08 08:55:07
| 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 July 31, 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 24716 |
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