81 FR 94384 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Regulatory Science Student Internship Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 247 (December 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 247 (December 23, 2016)
| Page Range | 94384-94386 | |
| FR Document | 2016-30967 |
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)] [Notices] [Pages 94384-94386] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30967] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-4342] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Regulatory Science Student Internship Program 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in FDA's Regulatory Science Student Internship Program (RSIP). DATES: Submit either electronic or written comments on the collection of information by February 21, 2017. ADDRESSES: You may submit comments as follows: [[Page 94385]] Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-4342 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the FDA Regulatory Science Student Internship Program.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://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 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. Application for Participation in the FDA Regulatory Science Student Internship Program--OMB Control Number 0910-New Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code, authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the RSIP will allow FDA's Office of the Commissioner to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA. FDA estimates the burden of this collection of information as follows: [[Page 94386]] Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Application..................... 600 1 600 1.33 798 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-30967 Filed 12-22-16; 8:45 am] BILLING CODE 4164-01-P
![94384 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
B. Earlier Stakeholder Involvement in annually through FY 2025 so that by review timelines and statutory
Guidance Development 2025, FDA and stakeholders will have obligations. In addition, the Agency is
CDRH has received feedback that assessed the applicability of all not precluded from issuing guidance
stakeholders desire earlier involvement guidances older than 10 years. For documents that are not on either list.
in the guidance process and has taken instance, in the annual notice for FY Stakeholder feedback on guidance
steps to create a mechanism to address 2018, CDRH expects to provide a list of priorities is important to ensure that the
this request. In FY 2016, in anticipation the final guidance documents that CDRH guidance program meets the
of guidance documents expected to be issued in 2008, 1998, 1988, and 1978; needs of stakeholders. The feedback
developed, CDRH sought stakeholder the annual notice for FY 2019 is received on the FY 2016 list was mostly
input regarding electromagnetic expected to provide a list of the final in agreement, and CDRH continued to
compatibility of electrically powered guidance documents that issued in work toward issuing the guidances on
medical devices and regarding utilizing 2009, 1999, 1989, and 1979, and so on. this list. In FY 2016, CDRH issued 20 of
animal studies to evaluate the safety of CDRH will consider the comments 33 guidances on the FY 2016 list (14
organ preservation devices and received from this retrospective review from the A-list, 6 from the B-list). In
solutions. FDA appreciated the feedback when determining priorities for addition, for the guidances that were on
received and considered it in the updating guidance documents and will the FY 2016 A or B list but could not
development of these guidances. revise these as resources permit. be published within FY 2016, and for
Demonstrating commitment to In FY 2016, CDRH received comments which we received feedback that these
incorporating stakeholder input, CDRH regarding guidances issued in 2006, guidances were of high priority, CDRH
has included these guidances topics on 1996, and 1986, and has withdrawn 12 has recommitted to publish these
the FY 2017 B-List as we progress guidance documents in response to guidances by placing them on the
toward issuance of draft policies comments received and because these annual agenda for FY 2017, as
reflecting early stakeholder input as guidance documents were determined appropriate.
appropriate. to no longer represent the Agency’s
current thinking. One guidance on this Dated: December 19, 2016.
We also welcome any additional Leslie Kux,
feedback for improving the guidance retrospective review list was revised,
and revision of several guidance Associate Commissioner for Policy.
program and the quality of CDRH
guidance documents. documents is also being considered as [FR Doc. 2016–31006 Filed 12–22–16; 8:45 am]
resources permit. BILLING CODE 4164–01–P
C. Applicability of Previously Issued Consistent with Good Guidance
Final Guidance Practices regulation at 21 CFR
CDRH has issued over 500 final 10.115(f)(4), CDRH would appreciate DEPARTMENT OF HEALTH AND
guidance documents to provide suggestions that CDRH revise or HUMAN SERVICES
stakeholders with the Agency’s thinking withdraw an already existing guidance
on numerous topics. Each guidance document. We request that the Food and Drug Administration
reflected the Agency’s current position suggestion clearly explain why the
at the time that it was issued. However, guidance document should be revised or [Docket No. FDA–2016–N–4342]
the guidance program has issued these withdrawn and, if applicable, how it
guidances over a period of 30 years, should be revised. While we are Agency Information Collection
raising the question of how current requesting feedback on the list of Activities; Proposed Collection;
previously issued final guidances previously issued final guidances Comment Request; Application for
remain. CDRH has resolved to address located in the annual agenda Web site, Participation in the Food and Drug
this concern through a staged review of feedback on any guidance is appreciated Administration Regulatory Science
previously issued final guidances in and will be considered. Student Internship Program
collaboration with stakeholders. At the III. Web Site Location of Guidance Lists AGENCY: Food and Drug Administration,
Web site where CDRH has posted the HHS.
‘‘A-list’’ and ‘‘B-list’’ for FY 2017, CDRH This notice announces the Web site
location of the document that provides ACTION: Notice.
has also posted a list of final guidance
documents that issued in 2007, 1997, the A and B lists of guidance
documents, which CDRH is intending to SUMMARY: The Food and Drug
1987, and 1977.1 CDRH is interested in Administration (FDA) is announcing an
external feedback on whether any of publish during FY 2017. To access these
two lists, visit FDA’s Web site at http:// opportunity for public comment on the
these final guidances should be revised proposed collection of certain
or withdrawn. In addition, for guidances www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/ information by the Agency. Under the
that are recommended for revision, Paperwork Reduction Act of 1995 (the
information explaining the need for GuidanceDocuments/ucm529396.htm.
We note that the topics on this and past PRA), Federal Agencies are required to
revision, such as, the impact and risk to publish notice in the Federal Register
public health associated with not guidance priority lists may be removed
or modified based on current priorities, concerning each proposed collection of
revising the guidance, would also be information and to allow 60 days for
helpful as the Center considers potential as well as comments received regarding
these lists. Furthermore, FDA and CDRH public comment in response to the
action with respect to these guidances. notice. This notice solicits comments on
CDRH intends to provide these lists of priorities are subject to change at any
time (e.g., newly identified safety the application for participation in
mstockstill on DSK3G9T082PROD with NOTICES
previously issued final guidances FDA’s Regulatory Science Student
issues). Topics on this and past
1 The retrospective list of final guidances does not guidance priority lists may be removed Internship Program (RSIP).
include the following: (1) Documents that are not or modified based on current priorities. DATES: Submit either electronic or
guidances but were inadvertently categorized as The Agency is not required to publish written comments on the collection of
guidance such as scientific publications, advisory information by February 21, 2017.
opinions, and interagency agreements; (2)
every guidance on either list if the
guidances actively being revised by CDRH; and (3) resources needed would be to the ADDRESSES: You may submit comments
special controls documents. detriment of meeting quantitative as follows:
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![94386 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of
Activity responses per annual burden per Total hours
respondents respondent responses response
Application ............................................................................ 600 1 600 1.33 798
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 19, 2016. Unique Device Identification System label of that device and utilize the
Leslie Kux, OMB Control Number 0910–0720— GUDID.
Associate Commissioner for Policy. Extension Under § 801.45, any device that has to
[FR Doc. 2016–30967 Filed 12–22–16; 8:45 am] be labeled with a UDI also has to bear
In accordance with the collection of
a permanent marking providing the UDI
BILLING CODE 4164–01–P information entitled ‘‘Unique Device
on the device itself if the device is
Identification System (UDI),’’ medical
intended for more than one use and
device labelers, unless excepted, are
DEPARTMENT OF HEALTH AND intended to be reprocessed before each
required to design and use medical
HUMAN SERVICES use.
device labels and device packages that
Section 801.50 requires stand-alone
bear a UDI, present dates on labels in a
Food and Drug Administration software to comply with specific
particular format, and submit data
labeling requirements that identify the
concerning each version or model of a
[Docket No. FDA–2016–N–4319] software.
device to the Global Unique Device Section 801.55 authorizes additional,
Identification Database (GUDID) no later case-by-case, labeling exceptions and
Agency Information Collection
than the date the label of the device alternatives to standard UDI labeling
Activities; Submission for Office of
must bear a UDI. Once a device becomes requirements.
Management and Budget Review;
subject to UDI requirements, If a labeler relabels or modifies a label
Comment Request; Unique Device
respondents will be required to update of a device that is required to bear a
Identification System
the information reported whenever the UDI, under § 830.60 it has to keep a
AGENCY: Food and Drug Administration, information changes. record showing the relationship of the
HHS. The recordkeeping, reporting, and original device identifier to the new
ACTION: Notice. third-party disclosure requirements device identifier.
referenced in this document are Section 830.110 requires an applicant
SUMMARY: The Food and Drug imposed on any person who causes a seeking initial FDA accreditation as a
Administration (FDA) is announcing label to be applied to a device, or who UDI-issuing agency to furnish FDA an
that a proposed collection of causes the label to be modified, with the application containing certain
information has been submitted to the intent that the device will be information, materials, and supporting
Office of Management and Budget commercially distributed without any documentation.
(OMB) for review and clearance under subsequent replacement or modification Under § 830.120, an FDA-accredited
the Paperwork Reduction Act of 1995. of the label. In most instances, the issuing agency is required to disclose
DATES: Fax written comments on the labeler would be the device information concerning its system for
collection of information by January 23, manufacturer, but other types of labelers the assignment of UDIs; maintain a list
2017. include a specification developer, a of labelers that use its system for the
single-use device reprocessor, a assignment of UDIs, and provide FDA a
ADDRESSES: To ensure that comments on
convenience kit assembler, a repackager, copy of such list; and upon request,
the information collection are received, or a relabeler. Respondents may also
OMB recommends that written provide FDA with information
include any private organization that concerning a labeler that is employing
comments be faxed to the Office of applies for accreditation by FDA as an
Information and Regulatory Affairs, the issuing agency’s system for
issuing agency. assignment of UDIs.
OMB, Attn: FDA Desk Officer, FAX:
FDA has identified the following Sections 830.310 and 830.320 require
202–395–7285, or emailed to oira_
requirements as having burdens that the labeler to provide certain
submission@omb.eop.gov. All
must be accounted for under the PRA; information to the GUDID concerning
comments should be identified with the
the burdens associated with these the labeler and each version or model of
OMB control number 0910–0720. Also
requirements are summarized in the a device required to be labeled with a
include the FDA docket number found
table that follows: UDI, unless the labeler obtains a waiver.
in brackets in the heading of this
Section 801.18 requires that whenever Section 830.360 requires each labeler
document.
a labeler of a medical device includes an to retain records showing all UDIs used
FOR FURTHER INFORMATION CONTACT: FDA expiration date, a date of manufacture, to identify devices that must be labeled
PRA Staff, Office of Operations, Food or any other date intended to be brought with a UDI and the particular version or
and Drug Administration, Three White to the attention of the user of the device, model associated with each device
Flint North 10A–12M, 11601 the labeler must present the date on the identifier, until 3 years after it ceases to
mstockstill on DSK3G9T082PROD with NOTICES
Landsdown St., North Bethesda, MD label in a format that meets the market a version or model of a device.
20852, PRAStaff@fda.hhs.gov. requirements of this section. Respondents who are required to
SUPPLEMENTARY INFORMATION: In Section 801.20 requires every medical submit data to the Agency under certain
compliance with 44 U.S.C. 3507, FDA device label and package to bear a UDI. other approved information collections
has submitted the following proposed Under § 801.35, any labeler of a (listed below) are required to include
collection of information to OMB for device that is not required to bear a UDI UDI data elements for the device that is
review and clearance. on its label may include a UDI on the the subject of such information
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Document Created: 2016-12-23 12:29:23
Document Modified: 2016-12-23 12:29:23
| 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 21, 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 94384 |
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