83 FR 53065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 203 (October 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 53065-53067 | |
| FR Document | 2018-22821 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Notices] [Pages 53065-53067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22821] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1072] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs 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 ``Application for Participation in FDA Fellowship and Traineeship Programs.'' DATES: Submit either electronic or written comments on the collection of information by December 18, 2018. 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 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 18, 2018. 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-2014-N-1072 for ``Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs.'' 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 [[Page 53066]] 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, 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. Application for Participation in FDA Fellowship and Traineeship Programs OMB Control Number 0910-0780--Revision 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. The proposed information collection involves brief online applications completed by applicants applying to FDA's Fellowship and Traineeship programs. These voluntary online applications will allow the Agency to easily and efficiently elicit and review information from students and healthcare 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: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Commissioner's Fellowship 600 1 600 1.33 798 Program........................ Regulatory Science Internship 250 1 250 1 250 Program........................ Medical Device Fellowship 250 1 250 1 250 Program........................ FDA Traineeship Program......... 1000 1 1000 1 1000 Reagan-Udall Fellowship at FDA.. 50 1 50 1 50 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 2,348 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Because FDA is developing two new training programs, our estimated burden for the information collection reflects an overall increase of 1,050 hours and a corresponding increase of 1,050 responses/records. We attribute this adjustment to an increase in the number of submissions that we will receive with the new training programs. [[Page 53067]] Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22821 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices 53065
Regulations and with applicable ACL published a Federal Register The proposed data collection tools
provisions of the HHS Regulations at 45 Notice regarding the independent living may be found on the ACL website for
CFR part 75. The PPR serves as the programs information collection on review at https://www.acl.gov/about-
primary basis for ACL’s monitoring February 23, 2017. Two-hundred and acl/public-input.
activities in fulfillment of its twenty-one individual comments were Estimated Program Burden: ACL
responsibilities under sections 706 and received. The responses indicated a estimates the burden of this collection
722 of the Act. The PPR also enables need to make substantial changes to the of information as follows: 353 Centers
ACL to track performance outcomes and collection. The current version of the for Independent Living will each
efficiency measures of the Centers for ILS PPR that ILA is requesting an complete one CIL PPR annually, and it
Independent Living (CIL) programs with extension for was approved by OMB, will take an estimated 35 hours per CIL
respect to the annual and long-term but will expire on December 31, 2018. for an estimated total of 12,355 hours.
performance targets established in Further deliberation is needed to ensure This burden estimate is based partly on
ILA’s estimates of how long CILs
compliance with GPRA. The PPR is also that we appropriately address all of the
probably take to find the information
used by ACL to design CIL and SILC concerns. ILA is proposing to extend the
that PPRs ask for and partly on what
training and technical assistance currently approved forms for three years CILs have told the Independent Living
programs authorized by section 711A while we work on a revision that Administration about how long filling
and section 721 of the Act. addresses all the suggested changes. out the PPRs took.
Responses
Number of Hours per Annual
Respondent/data collection activity per
respondents response burden hours
respondent
Centers for Independent Living ....................................................................... 353 1 35 12,355
Dated: October 9, 2018. DATES: Submit either electronic or • If you want to submit a comment
Mary Lazare, written comments on the collection of with confidential information that you
Principal Deputy Administrator. information by December 18, 2018. do not wish to be made available to the
[FR Doc. 2018–22754 Filed 10–18–18; 8:45 am] ADDRESSES: You may submit comments public, submit the comment as a
BILLING CODE 4154–01–P
as follows. Please note that late, written/paper submission and in the
untimely filed comments will not be manner detailed (see ‘‘Written/Paper
considered. Electronic comments must Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND be submitted on or before December 18, Written/Paper Submissions
HUMAN SERVICES 2018. The https://www.regulations.gov
electronic filing system will accept Submit written/paper submissions as
Food and Drug Administration comments until 11:59 p.m. Eastern Time follows:
at the end of December 18, 2018. • Mail/Hand delivery/Courier (for
Comments received by mail/hand written/paper submissions): Dockets
[Docket No. FDA–2014–N–1072]
delivery/courier (for written/paper Management Staff (HFA–305), Food and
Agency Information Collection submissions) will be considered timely Drug Administration, 5630 Fishers
Activities; Proposed Collection; if they are postmarked or the delivery Lane, Rm. 1061, Rockville, MD 20852.
Comment Request; Application for service acceptance receipt is on or • For written/paper comments
Participation in Food and Drug before that date. submitted to the Dockets Management
Administration Fellowship and Staff, FDA will post your comment, as
Electronic Submissions well as any attachments, except for
Traineeship Programs
Submit electronic comments in the information submitted, marked and
AGENCY: Food and Drug Administration, following way: identified, as confidential, if submitted
HHS. • Federal eRulemaking Portal: as detailed in ‘‘Instructions.’’
https://www.regulations.gov. Follow the Instructions: All submissions received
ACTION: Notice. instructions for submitting comments. must include the Docket No. FDA–
Comments submitted electronically, 2014–N–1072 for ‘‘Application for
SUMMARY: The Food and Drug including attachments, to https:// Participation in Food and Drug
Administration (FDA or Agency) is www.regulations.gov will be posted to Administration Fellowship and
announcing an opportunity for public the docket unchanged. Because your Traineeship Programs.’’ Received
comment on the proposed collection of comment will be made public, you are comments, those filed in a timely
certain information by the Agency. solely responsible for ensuring that your manner (see ADDRESSES), will be placed
Under the Paperwork Reduction Act of comment does not include any in the docket and, except for those
1995 (PRA), Federal Agencies are confidential information that you or a submitted as ‘‘Confidential
required to publish notice in the third party may not wish to be posted, Submissions,’’ publicly viewable at
Federal Register concerning each such as medical information, your or https://www.regulations.gov or at the
proposed collection of information, anyone else’s Social Security number, or Dockets Management Staff between 9
amozie on DSK3GDR082PROD with NOTICES1
including each proposed extension of an confidential business information, such a.m. and 4 p.m., Monday through
existing collection of information, and as a manufacturing process. Please note Friday.
to allow 60 days for public comment in that if you include your name, contact • Confidential Submissions—To
response to the notice. This notice information, or other information that submit a comment with confidential
solicits comments on ‘‘Application for identifies you in the body of your information that you do not wish to be
Participation in FDA Fellowship and comments, that information will be made publicly available, submit your
Traineeship Programs.’’ posted on https://www.regulations.gov. comments only as a written/paper
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![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices 53067
Dated: October 15, 2018. Electronic Submissions submission. You should submit two
Leslie Kux, Submit electronic comments in the copies total. One copy will include the
Associate Commissioner for Policy. following way: information you claim to be confidential
[FR Doc. 2018–22821 Filed 10–18–18; 8:45 am] • Federal eRulemaking Portal: with a heading or cover note that states
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically, Agency will review this copy, including
DEPARTMENT OF HEALTH AND including attachments, to https:// the claimed confidential information, in
HUMAN SERVICES www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Food and Drug Administration comment will be made public, you are claimed confidential information
solely responsible for ensuring that your redacted/blacked out, will be available
[Docket Nos. FDA–2017–E–6544 and FDA– comment does not include any for public viewing and posted on
2017–E–6542] confidential information that you or a https://www.regulations.gov. Submit
third party may not wish to be posted, both copies to the Dockets Management
Determination of Regulatory Review such as medical information, your or Staff. If you do not wish your name and
Period for Purposes of Patent anyone else’s Social Security number, or contact information to be made publicly
Extension; IMFINZI confidential business information, such
available, you can provide this
as a manufacturing process. Please note
AGENCY: Food and Drug Administration, information on the cover sheet and not
that if you include your name, contact
HHS. information, or other information that in the body of your comments and you
identifies you in the body of your must identify this information as
ACTION: Notice. ‘‘confidential.’’ Any information marked
comments, that information will be
posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
SUMMARY: The Food and Drug • If you want to submit a comment except in accordance with § 10.20 (21
Administration (FDA or the Agency) has with confidential information that you CFR 10.20) and other applicable
determined the regulatory review period do not wish to be made available to the disclosure law. For more information
for IMFINZI and is publishing this public, submit the comment as a about FDA’s posting of comments to
notice of that determination as required written/paper submission and in the public dockets, see 80 FR 56469,
by law. FDA has made the manner detailed (see ‘‘Written/Paper September 18, 2015, or access the
determination because of the Submissions’’ and ‘‘Instructions’’). information at: https://www.gpo.gov/
submission of applications to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Director of the U.S. Patent and Written/Paper Submissions
23389.pdf.
Trademark Office (USPTO), Department Submit written/paper submissions as
of Commerce, for the extension of a follows: Docket: For access to the docket to
patent which claims that human • Mail/Hand delivery/Courier (for read background documents or the
biological product. written/paper submissions): Dockets electronic and written/paper comments
Management Staff (HFA–305), Food and received, go to https://
DATES: Anyone with knowledge that any www.regulations.gov and insert the
of the dates as published (see the Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic • For written/paper comments heading of this document, into the
submitted to the Dockets Management ‘‘Search’’ box and follow the prompts
or written comments and ask for a
redetermination by December 18, 2018. Staff, FDA will post your comment, as and/or go to the Dockets Management
Furthermore, any interested person may well as any attachments, except for Staff, 5630 Fishers Lane, Rm. 1061,
petition FDA for a determination information submitted, marked and Rockville, MD 20852.
regarding whether the applicant for identified, as confidential, if submitted
FOR FURTHER INFORMATION CONTACT:
extension acted with due diligence as detailed in ‘‘Instructions.’’
Instructions: All submissions received Beverly Friedman, Office of Regulatory
during the regulatory review period by Policy, Food and Drug Administration,
April 17, 2019. See ‘‘Petitions’’ in the must include the Docket Nos. FDA–
2017–E–6544 and FDA–2017–E–6542 10903 New Hampshire Ave. Bldg. 51,
SUPPLEMENTARY INFORMATION section for Rm. 6250, Silver Spring, MD 20993,
more information. for ‘‘Determination of Regulatory
Review Period for Purposes of Patent 301–796–3600.
ADDRESSES: You may submit comments Extension; IMFINZI.’’ Received SUPPLEMENTARY INFORMATION:
as follows. Please note that late, comments, those filed in a timely
untimely filed comments will not be manner (see ADDRESSES), will be placed I. Background
considered. Electronic comments must in the docket and, except for those
be submitted on or before April 17, submitted as ‘‘Confidential The Drug Price Competition and
2019. The https://www.regulations.gov Submissions,’’ publicly viewable at Patent Term Restoration Act of 1984
electronic filing system will accept https://www.regulations.gov or at the (Pub. L. 98–417) and the Generic
comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9 Animal Drug and Patent Term
amozie on DSK3GDR082PROD with NOTICES1
at the end of April 17, 2019. Comments a.m. and 4 p.m., Monday through Restoration Act (Pub. L. 100–670)
received by mail/hand delivery/courier Friday. generally provide that a patent may be
(for written/paper submissions) will be • Confidential Submissions—To extended for a period of up to 5 years
considered timely if they are submit a comment with confidential so long as the patented item (human
postmarked or the delivery service information that you do not wish to be drug product, animal drug product,
acceptance receipt is on or before that made publicly available, submit your medical device, food additive, or color
date. comments only as a written/paper additive) was subject to regulatory
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Document Created: 2018-10-19 01:25:16
Document Modified: 2018-10-19 01:25:16
| 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 18, 2018. | |
| 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 | 83 FR 53065 |
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