82 FR 50145 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50145-50147 | |
| FR Document | 2017-23515 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Notices] [Pages 50145-50147] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23515] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5975] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows AGENCY: Food and Drug Administration, HHS. [[Page 50146]] 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Survey of Alumni Commissioner's Fellowship Program Fellows. DATES: Submit either electronic or written comments on the collection of information by December 29, 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 December 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 29, 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): 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-2017-N-5975 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows.'' 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 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: 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 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. Survey of Alumni Commissioner's Fellowship Program Fellows--OMB Control Number 0910--NEW FDA is requesting approval from OMB to gather information from Alumni Commissioner's Fellowship Program (CFP) Fellows. The information from Alumni CFP Fellows will allow FDA's Office of the Commissioner (OC) to [[Page 50147]] easily and efficiently elicit and review program feedback. The online voluntary survey will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their experience with the FDA while a Commissioner's Fellow. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of surveys being misrouted within the Agency mail system. The information gathered by the survey will be used to gain insights into, and to document, impacts that the CFP has had and is having on former CFP fellows and contributions and impacts that the former fellows are making in their current work. The voluntary surveys include questions to assess the following measures: Post-fellowship employment (e.g., employment type); number of awards; number of contributions while a CFP fellow (e.g., number of publications, guidance documents authored or co-authored); and contributions in their field (e.g., list of publications). 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Fellowship Program Survey.......................................... 35 1 35 * 0.50 17.5 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating maintenance costs associated with this collection of information. * 30 minutes. FDA based these estimates on the number of fellows who have graduated and left the Agency over the past 5 years. Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23515 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50145
Silver Spring, MD 20993–0002. Send We believe De Novo classification Health guidance documents is available
one self-addressed adhesive label to will enhance patients’ access to at https://www.fda.gov/MedicalDevices/
assist that office in processing your beneficial innovation, in part by DeviceRegulationandGuidance/
request. reducing regulatory burdens. When FDA GuidanceDocuments/default.htm.
classifies a device into class I or II via Guidance documents are also available
FOR FURTHER INFORMATION CONTACT:
the De Novo classification process, the at https://www.regulations.gov. Persons
Sergio de del Castillo, Center for device can serve as a predicate for unable to download an electronic copy
Devices and Radiological Health, Food future devices of that type, including for of ‘‘De Novo Classification Process
and Drug Administration, 10903 New 510(k)s (section 513(f)(2)(B)(i)). As a (Evaluation of Automatic Class III
Hampshire Ave., Bldg. 66, Rm. 1538, result, other device sponsors do not Designation)’’ may send an email
Silver Spring, MD 20993–0002, 301– have to submit a De Novo request or request to CDRH-Guidance@fda.hhs.gov
796–6419; and Stephen Ripley, Center PMA in order to market a substantially to receive an electronic copy of the
for Biologics Evaluation and Research, equivalent device (see 21 U.S.C. 360c(i), document. Please use the document
Food and Drug Administration, 10903 defining ‘‘substantial equivalence’’). number 1760 to identify the guidance
New Hampshire Ave., Bldg. 71, Rm. Instead, sponsors can use the less- you are requesting.
7301, Silver Spring, MD 20993–0002, burdensome 510(k) process, when
301–240–402–7911. applicable, as a pathway to market their IV. Paperwork Reduction Act of 1995
SUPPLEMENTARY INFORMATION: device. This guidance refers to previously
FDA is issuing this document to approved collections of information
I. Background provide guidance on the process for the found in FDA regulations. These
The automatic class III designation for submission and review of a De Novo collections of information are subject to
devices of a new type occurs by request under section 513(f)(2) of the review by the Office of Management and
operation of law and without any action FD&C Act, also known as the De Novo Budget (OMB) under the Paperwork
by FDA, regardless of the level of risk classification process. This guidance Reduction Act of 1995 (44 U.S.C. 3501–
posed. Any device that is of a new type also provides updated recommendations 3520). The collections of information in
that was not in commercial distribution for interactions with FDA related to the the guidance ‘‘De Novo Classification
before May 28, 1976, is automatically De Novo classification process, Process (Evaluation of Automatic Class
classified as, and remains within, class including what information to submit III Designation)’’ have been approved
III and requires premarket approval when seeking a path to market via the under OMB control number 0910–0844.
unless and until FDA takes an action to De Novo classification process. This The collections of information in the
classify or reclassify the device section guidance will provide clarity regarding guidance document ‘‘Requests for
513(f)(1) of the FD&C Act (21 U.S.C. the Agency’s review process and Feedback on Medical Device
360c(f)(1)). We refer to these devices as expectations for information to be Submissions: The Pre-Submission
‘‘postamendments devices’’ because submitted in a De Novo request and Program and Meetings with Food and
they were not in commercial ensures predictability and consistency Drug Administration Staff’’ have been
distribution prior to the date of for sponsors. approved under OMB control number
enactment of the Medical Device FDA considered comments received 0910–0756. The collections of
Amendments of 1976. on the draft guidance that appeared in information in 21 CFR part 807, subpart
the Federal Register (79 FR 47651) of E have been approved under OMB
FDA may classify a device through
August 14, 2014. FDA revised the control number 0910–0120; the
the De Novo classification process,
guidance as appropriate in response to collections of information in 21 CFR
which is the pathway authorized under
the comments. This document part 814 have been approved under
section 513(f)(2) of the FD&C Act (21
supersedes ‘‘New Section 513(f)(2)— OMB control number 0910–0231; and
U.S.C. 360c(f)(2)). A person may submit
Evaluation of Automatic Class III the collections of information in 21 CFR
a De Novo request after submitting a
Designation, Guidance for Industry and part 801 have been approved under
premarket notification under section
CDRH Staff’’ dated February 19, 1998. OMB control number 0910–0485.
510(k) of the FD&C Act and receiving a
not substantially equivalent (NSE) II. Significance of Guidance Dated: October 24, 2017.
determination (section 513(f)(2)(A)(i) of This guidance is being issued Anna K. Abram,
the FD&C Act). A person may also consistent with FDA’s good guidance Deputy Commissioner for Policy, Planning,
submit a De Novo request without first practices regulation (21 CFR 10.115). Legislation, and Analysis.
submitting a premarket notification The guidance represents the current [FR Doc. 2017–23492 Filed 10–27–17; 8:45 am]
under section 510(k), if the person thinking of FDA on the De Novo BILLING CODE 4164–01–P
determines that there is no legally Classification Process (Evaluation of
marketed device upon which to base a Automatic Class III Designation). It does
determination of substantial not establish any rights for any person DEPARTMENT OF HEALTH AND
equivalence (section 513(f)(2)(A)(ii) of and is not binding on FDA or the public. HUMAN SERVICES
the FD&C Act). You can use an alternative approach if
Upon receipt of a De Novo request, it satisfies the requirements of the Food and Drug Administration
FDA is required to classify the device by applicable statutes and regulations. This
written order (section 513(f)(2)(A)(iii) of [Docket No. FDA–2017–N–5975]
guidance is not subject to Executive
the FD&C Act). The classification will
sradovich on DSK3GMQ082PROD with NOTICES
Order 12866. Agency Information Collection
be according to the criteria under Activities; Proposed Collection;
section 513(a)(1) of the FD&C Act (21 III. Electronic Access
Comment Request; Survey of Alumni
U.S.C. 360c(a)(1)). Per section Persons interested in obtaining a copy Commissioner’s Fellowship Program
513(f)(2)(B)(i) of the FD&C Act, the of the guidance may do so by Fellows
classification is the initial classification downloading an electronic copy from
of the device for the purposes of section the Internet. A search capability for all AGENCY: Food and Drug Administration,
513(f)(1) of the FD&C Act. Center for Devices and Radiological HHS.
VerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/82_FR_50353/page/1.svg)
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50147
easily and efficiently elicit and review surveys being misrouted within the following measures: Post-fellowship
program feedback. The online voluntary Agency mail system. The information employment (e.g., employment type);
survey will assist the Agency in gathered by the survey will be used to number of awards; number of
promoting and protecting the public gain insights into, and to document, contributions while a CFP fellow (e.g.,
health by encouraging outside persons impacts that the CFP has had and is number of publications, guidance
to share their experience with the FDA having on former CFP fellows and documents authored or co-authored);
while a Commissioner’s Fellow. The contributions and impacts that the and contributions in their field (e.g., list
process will reduce the time and cost of former fellows are making in their of publications).
submitting written documentation to the current work. The voluntary surveys FDA estimates the burden of this
Agency and lessen the likelihood of include questions to assess the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Fellowship Program Survey ................................................. 35 1 35 * 0.50 17.5
1 There are no capital costs or operating maintenance costs associated with this collection of information.
* 30 minutes.
FDA based these estimates on the Manufacturing and Product Quality • If you want to submit a comment
number of fellows who have graduated Program; Public Workshop; Request for with confidential information that you
and left the Agency over the past 5 Comments’’ published on July 25, 2017 do not wish to be made available to the
years. (82 FR 34531). Submit either electronic public, submit the comment as a
Dated: October 24, 2017. or written comments on this public written/paper submission and in the
workshop by December 14, 2017. manner detailed (see ‘‘Written/Paper
Anna K. Abram,
Submissions’’ and ‘‘Instructions’’).
Deputy Commissioner for Policy, Planning, ADDRESSES: You may submit comments
Legislation, and Analysis. as follows. Please note that late, Written/Paper Submissions
[FR Doc. 2017–23515 Filed 10–27–17; 8:45 am] untimely filed comments will not be Submit written/paper submissions as
BILLING CODE 4164–01–P considered. Electronic comments must follows:
be submitted on or before December 14, • Mail/Hand delivery/Courier (for
2017. The https://www.regulations.gov written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND electronic filing system will accept Management Staff (HFA–305), Food and
HUMAN SERVICES comments until midnight Eastern Time Drug Administration, 5630 Fishers
at the end of December 14, 2017. Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration Comments received by mail/hand • For written/paper comments
[Docket No. FDA–2017–N–4180] delivery/courier (for written/paper submitted to the Dockets Management
submissions) will be considered timely Staff, FDA will post your comment, as
Voluntary Medical Device if they are postmarked or the delivery well as any attachments, except for
Manufacturing and Product Quality service acceptance receipt is on or information submitted, marked and
Program; Public Workshop; Request before that date. identified, as confidential, if submitted
for Comments; Reopening of Comment as detailed in ‘‘Instructions.’’
Period Electronic Submissions Instructions: All submissions received
must include the Docket No. FDA–
AGENCY: Food and Drug Administration, Submit electronic comments in the
2017–N–4180 for ‘‘Voluntary Medical
HHS. following way:
Device Manufacturing and Product
Notice; reopening of the
ACTION: • Federal eRulemaking Portal: Quality Program; Public Workshop;
comment period. https://www.regulations.gov. Follow the Request for Comments; Reopening of
instructions for submitting comments. Comment Period.’’ Received comments,
SUMMARY: The Food and Drug Comments submitted electronically, those filed in a timely manner (see
Administration (FDA or the Agency) is including attachments, to https:// ADDRESSES), will be placed in the docket
reopening the comment period provided www.regulations.gov will be posted to and, except for those submitted as
in the notice entitled ‘‘Voluntary the docket unchanged. Because your ‘‘Confidential Submissions,’’ publicly
Medical Device Manufacturing and comment will be made public, you are viewable at https://www.regulations.gov
Product Quality Program; Public solely responsible for ensuring that your or at the Dockets Management Staff
Workshop; Request for Comments,’’ comment does not include any between 9 a.m. and 4 p.m., Monday
published in the Federal Register of confidential information that you or a through Friday.
July 25, 2017 (82 FR 34531). That notice third party may not wish to be posted, • Confidential Submissions—To
announced the public workshop to be such as medical information, your or submit a comment with confidential
held on October 10, 2017, and requested anyone else’s Social Security number, or information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
comments by October 18, 2017. The confidential business information, such made publicly available, submit your
Agency is taking this action to allow as a manufacturing process. Please note comments only as a written/paper
interested parties additional time to that if you include your name, contact submission. You should submit two
submit comments. information, or other information that copies total. One copy will include the
DATES: FDA is reopening the comment identifies you in the body of your information you claim to be confidential
period for the public workshop comments, that information will be with a heading or cover note that states
‘‘Voluntary Medical Device posted on https://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS
VerDate Sep<11>2014 18:51 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/82_FR_50353/page/3.svg)
Document Created: 2017-10-28 00:28:30
Document Modified: 2017-10-28 00:28:30
| 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 December 29, 2017. | |
| 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] | |
| FR Citation | 82 FR 50145 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR