82 FR 28075 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship Programs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 117 (June 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 117 (June 20, 2017)
| Page Range | 28075-28076 | |
| FR Document | 2017-12781 |
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)] [Notices] [Pages 28075-28076] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12781] ----------------------------------------------------------------------- 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 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 Programs.'' DATES: Submit either electronic or written comments on the collection of information by August 21, 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 August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 21, 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-2014-N-1072 for ``Application for Participation in Food and Drug Administration Fellowship 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 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, 10A63, 11601 Landsdown St., North Bethesda, MD [[Page 28076]] 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 Programs (Formerly Application for Participation in the FDA Commissioner's Fellowship Program) OMB Control Number 0910-0780--Extension 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 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 Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses 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........................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,298 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12781 Filed 6-19-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices 28075
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses
Activity annual burden per Total hours
respondents per responses response
respondent
FDA Rapid Response Survey .................................. 10,000 6 60,000 0.5 (30 minutes) ........ 30,000
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017. service acceptance receipt is on or Submissions,’’ publicly viewable at
Anna K. Abram, before that date. https://www.regulations.gov or at the
Deputy Commissioner for Policy, Planning, Dockets Management Staff between 9
Electronic Submissions
Legislation, and Analysis. a.m. and 4 p.m., Monday through
[FR Doc. 2017–12782 Filed 6–19–17; 8:45 am] Submit electronic comments in the Friday.
BILLING CODE 4164–01–P
following way: • Confidential Submissions—To
• Federal eRulemaking Portal:
submit a comment with confidential
https://www.regulations.gov. Follow the
information that you do not wish to be
DEPARTMENT OF HEALTH AND instructions for submitting comments.
Comments submitted electronically, made publicly available, submit your
HUMAN SERVICES comments only as a written/paper
including attachments, to https://
www.regulations.gov will be posted to submission. You should submit two
Food and Drug Administration copies total. One copy will include the
the docket unchanged. Because your
comment will be made public, you are information you claim to be confidential
[Docket No. FDA–2014–N–1072] with a heading or cover note that states
solely responsible for ensuring that your
comment does not include any ‘‘THIS DOCUMENT CONTAINS
Agency Information Collection
confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
Activities; Proposed Collection;
third party may not wish to be posted, Agency will review this copy, including
Comment Request; Application for
such as medical information, your or the claimed confidential information, in
Participation in Food and Drug
anyone else’s Social Security number, or its consideration of comments. The
Administration Fellowship Programs
confidential business information, such second copy, which will have the
AGENCY: Food and Drug Administration, as a manufacturing process. Please note claimed confidential information
HHS. that if you include your name, contact redacted/blacked out, will be available
ACTION: Notice. information, or other information that for public viewing and posted on
identifies you in the body of your https://www.regulations.gov. Submit
SUMMARY: The Food and Drug comments, that information will be both copies to the Dockets Management
Administration (FDA or Agency) is posted on https://www.regulations.gov. Staff. If you do not wish your name and
announcing an opportunity for public • If you want to submit a comment contact information to be made publicly
comment on the proposed collection of with confidential information that you available, you can provide this
certain information by the Agency. do not wish to be made available to the information on the cover sheet and not
Under the Paperwork Reduction Act of public, submit the comment as a in the body of your comments and you
1995 (PRA), Federal Agencies are written/paper submission and in the must identify this information as
required to publish notice in the manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
Federal Register concerning each Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
proposed collection of information, except in accordance with 21 CFR 10.20
including each proposed extension of an Written/Paper Submissions and other applicable disclosure law. For
existing collection of information, and Submit written/paper submissions as more information about FDA’s posting
to allow 60 days for public comment in follows: of comments to public dockets, see 80
response to the notice. This notice • Mail/Hand delivery/Courier (for FR 56469, September 18, 2015, or access
solicits comments on ‘‘Application for written/paper submissions): Dockets the information at: https://www.gpo.gov/
Participation in FDA Fellowship Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015-
Programs.’’ Drug Administration, 5630 Fishers 23389.pdf.
Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
DATES: Submit either electronic or • For written/paper comments
written comments on the collection of read background documents or the
submitted to the Dockets Management
information by August 21, 2017. electronic and written/paper comments
Staff, FDA will post your comment, as
ADDRESSES: You may submit comments
received, go to https://
well as any attachments, except for
as follows. Please note that late, www.regulations.gov and insert the
information submitted, marked and
untimely filed comments will not be docket number, found in brackets in the
identified, as confidential, if submitted
considered. Electronic comments must heading of this document, into the
as detailed in ‘‘Instructions.’’
be submitted on or before August 21, Instructions: All submissions received ‘‘Search’’ box and follow the prompts
2017. The https://www.regulations.gov must include the Docket No. FDA– and/or go to the Dockets Management
sradovich on DSK3GMQ082PROD with NOTICES
electronic filing system will accept 2014–N–1072 for ‘‘Application for Staff, 5630 Fishers Lane, Rm. 1061,
comments until midnight Eastern Time Participation in Food and Drug Rockville, MD 20852.
at the end of August 21, 2017. Administration Fellowship Programs.’’ FOR FURTHER INFORMATION CONTACT:
Comments received by mail/hand Received comments, those filed in a Amber Sanford, Office of Operations,
delivery/courier (for written/paper timely manner (see ADDRESSES), will be Food and Drug Administration, Three
submissions) will be considered timely placed in the docket and, except for White Flint North, 10A63, 11601
if they are postmarked or the delivery those submitted as ‘‘Confidential Landsdown St., North Bethesda, MD
VerDate Sep<11>2014 18:01 Jun 19, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\20JNN1.SGM 20JNN1](https://thefederalregister.org/doc/82_FR_28192/page/1.svg)
![28076 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
20852, 301–796–8867, PRAStaff@ comments on these topics: (1) Whether the United States Code authorize
fda.hhs.gov. the proposed collection of information Federal agencies to rate applicants for
SUPPLEMENTARY INFORMATION: Under the is necessary for the proper performance Federal jobs. The proposed information
PRA (44 U.S.C. 3501–3520), Federal of FDA’s functions, including whether collection involves brief online
Agencies must obtain approval from the the information will have practical applications completed by applicants
Office of Management and Budget utility; (2) the accuracy of FDA’s applying to FDA’s fellowship programs.
(OMB) for each collection of estimate of the burden of the proposed These voluntary online applications
information they conduct or sponsor. collection of information, including the will allow the Agency to easily and
‘‘Collection of information’’ is defined validity of the methodology and efficiently elicit and review information
in 44 U.S.C. 3502(3) and 5 CFR assumptions used; (3) ways to enhance
from students and healthcare
1320.3(c) and includes Agency requests the quality, utility, and clarity of the
professionals who are interested in
or requirements that members of the information to be collected; and (4)
ways to minimize the burden of the becoming involved in FDA-wide
public submit reports, keep records, or activities. The process will reduce the
provide information to a third party. collection of information on
respondents, including through the use time and cost of submitting written
Section 3506(c)(2)(A) of the PRA (44 documentation to the Agency and lessen
U.S.C. 3506(c)(2)(A)) requires Federal of automated collection techniques,
when appropriate, and other forms of the likelihood of applications being
Agencies to provide a 60-day notice in misrouted within the Agency mail
the Federal Register concerning each information technology.
system. It will assist the Agency in
proposed collection of information, Application for Participation in FDA promoting and protecting the public
including each proposed extension of an Fellowship Programs (Formerly
existing collection of information, health by encouraging outside persons
Application for Participation in the
before submitting the collection to OMB to share their expertise with FDA.
FDA Commissioner’s Fellowship
for approval. To comply with this Program) FDA estimates the burden of this
requirement, FDA is publishing notice collection of information as follows:
of the proposed collection of OMB Control Number 0910–0780—
information set forth in this document. Extension
With respect to the following Sections 1104, 1302, 3301, 3304,
collection of information, FDA invites 3320, 3361, 3393, and 3394 of Title 5 of
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of responses
Activity annual burden per Total hours
respondents per responses response
respondent
Commissioner’s Fellowship Program .................................. 600 1 600 1.33 798
Regulatory Science Internship Program .............................. 250 1 250 1 250
Medical Device Fellowship Program ................................... 250 1 250 1 250
Total .............................................................................. ........................ ........................ ........................ ........................ 1,298
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017. SUMMARY: The Food and Drug untimely filed comments will not be
Anna K. Abram, Administration (FDA or Agency) is considered. Electronic comments must
Deputy Commissioner for Policy, Planning, announcing an opportunity for public be submitted on or before August 21,
Legislation, and Analysis. comment on the proposed collection of 2017. The https://www.regulations.gov
[FR Doc. 2017–12781 Filed 6–19–17; 8:45 am] certain information by the Agency. electronic filing system will accept
BILLING CODE 4164–01–P Under the Paperwork Reduction Act of comments until midnight Eastern Time
1995 (PRA), Federal Agencies are at the end of August 21, 2017.
required to publish notice in the Comments received by mail/hand
DEPARTMENT OF HEALTH AND Federal Register concerning each delivery/courier (for written/paper
HUMAN SERVICES proposed collection of information, submissions) will be considered timely
including each proposed extension of an if they are postmarked or the delivery
Food and Drug Administration existing collection of information, and service acceptance receipt is on or
[Docket No. FDA–2013–N–1429] to allow 60 days for public comment in before that date.
response to the notice. This notice
Electronic Submissions
Agency Information Collection solicits comments on the information
Activities: Proposed Collection; collection in the guidance on Submit electronic comments in the
Comment Request; Guidance for registration of human drug following way:
Industry on Registration of Human compounding outsourcing facilities
• Federal eRulemaking Portal:
sradovich on DSK3GMQ082PROD with NOTICES
Drug Compounding Outsourcing under the Federal Food, Drug, and
https://www.regulations.gov. Follow the
Facilities Under Section 503B of the Cosmetic Act (the FD&C Act).
instructions for submitting comments.
Federal Food, Drug, and Cosmetic Act DATES: Submit either electronic or Comments submitted electronically,
written comments on the collection of including attachments, to https://
AGENCY: Food and Drug Administration,
information by August 21, 2017. www.regulations.gov will be posted to
HHS.
ADDRESSES: You may submit comments the docket unchanged. Because your
ACTION: Notice.
as follows. Please note that late, comment will be made public, you are
VerDate Sep<11>2014 18:01 Jun 19, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\20JNN1.SGM 20JNN1](https://thefederalregister.org/doc/82_FR_28192/page/2.svg)
Document Created: 2017-06-20 02:21:21
Document Modified: 2017-06-20 02:21:21
| 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 August 21, 2017. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 28075 |
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