83 FR 53257 - Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 204 (October 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 204 (October 22, 2018)
| Page Range | 53257-53259 | |
| FR Document | 2018-22960 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Notices] [Pages 53257-53259] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22960] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3728] Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee 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 the ``Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.'' DATES: Submit either electronic or written comments on the collection of information by December 21, 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 21, 2018]. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 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 [[Page 53258]] 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-2018-N-3728 for ``Collection of Conflict of Interest Information for Participation in FDA 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 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, PRAStaff@fda.hhs.gov. 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. Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs; OMB Control Number 0910--NEW In compliance with 44 U.S.C. 3507, FDA will submit to the Office of Management and Budget a request to review and approve a new collection of information: ``Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.'' Section 742 (b) of the Food, Drug and Cosmetic Act (21 U.S.C. 379l) allows FDA to conduct and support intramural training programs through fellowship and traineeship programs. These new forms provide the FDA with information about financial investments and relationships from non-employee scientists who participate in FDA fellowship and traineeship programs. Participants in FDA fellowship and traineeship programs will be asked for certain information about financial interests and current relationships: (1) Description of the financial interest; (2) the type of financial interest (e.g. stocks, bonds, stock options); (3) if the financial interest is an employee benefit from prior employment; (4) value of financial interest; (5) who owns the financial interest (e.g. self, spouse minor children); (6) employment relationship with an FDA significantly regulated organization (SRO); (7) and service as a consultant to an FDA SRO, and/ or proprietary interest(s) in one of more product(s) regulated by FDA, including patent, trademark, copyright, or licensing agreement. The purpose of the financial information is for FDA to determine if there is a conflict of interest between the Fellow's or Trainee's financial and relationship interests and their activities at FDA. The collection of information is mandatory to participate in FDA's fellowship and traineeship programs. FDA estimates the burden of this collection of information as follows: [[Page 53259]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Collection Form--Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA ---------------------------------------------------------------------------------------------------------------- Oak Ridge Institute for Science 500 1 500 1 500 and Education Fellowship....... Traineeship Program............. 500 1 500 1 500 Reagan-Udall Fellowship at FDA.. 50 1 50 1 50 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,050 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22960 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53257
gear that may not be protective against conditions for the sampled turnout gear (2) surveying the fire fighters assigned
all hazards is being used by fire fighters. will be determined, and the gear will be to each set of sampled gear to obtain
Intuitively, the use conditions to subjected to established performance one-month of retrospective information
which turnout gear would be exposed to requirements. For each set of gear, its about the use conditions to which it was
when used by a large or medium performance will be directly linked to likely exposed; and
metropolitan fire department would be its use condition history. This combined
very different than those of a smaller (3) a 6-month prospective data
lab and field data will help determine
department. However, the absence of collection where the fire fighters
if there is a relationship between
scientific data to link performance to assigned to each set of sampled gear
turnout gear use conditions and the
use conditions (e.g., number and type of provide information about their shift-
ability for turnout gear to effectively
washings, number of fire-related calls) specific exposures.
protect the user.
provides a barrier to transitioning to an The estimated annualized Burden
alternative approach to retirement. The use conditions for each set of
sampled gear will be determined by: Hours for this information collection is
This study will obtain a statistically 1,050. There is no cost to respondents
meaningful sample of turnout gear from (1) Reviewing fire department records, other than their time.
three fire departments. The use practices, and policies;
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Individual Fire Fighter ............. Turnout Gear Safety Survey—Retrospective Exposures for 100 1 30/60
past month.
Turnout Gear Safety Survey—Prospective Exposures for six 100 60 10/60
months.
Jeffrey M. Zirger, prompts to the desired center or product to allow 60 days for public comment in
Acting Chief, Information Collection Review area. Please call the Information Line for response to the notice. This notice
Office, Office of Scientific Integrity, Office up-to-date information on this meeting. solicits comments on the ‘‘Collection of
of the Associate Director for Science, Office Conflict of Interest Information for
Dated: October 16, 2018.
of the Director, Centers for Disease Control Participation in FDA Non-Employee
and Prevention. Leslie Kux,
Associate Commissioner for Policy.
Fellowship and Traineeship Programs.’’
[FR Doc. 2018–22939 Filed 10–19–18; 8:45 am]
[FR Doc. 2018–22942 Filed 10–19–18; 8:45 am] DATES: Submit either electronic or
BILLING CODE 4163–18–P
BILLING CODE 4164–01–P
written comments on the collection of
information by December 21, 2018.
DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
HUMAN SERVICES DEPARTMENT OF HEALTH AND as follows. Please note that late,
HUMAN SERVICES untimely filed comments will not be
Food and Drug Administration considered. Electronic comments must
Food and Drug Administration be submitted on or before December 21,
[Docket No. FDA–2018–N–3305]
[Docket No. FDA–2018–N–3728] 2018]. The https://www.regulations.gov
Allergenic Products Advisory electronic filing system will accept
Agency Information Collection comments until 11:59 p.m. Eastern Time
Committee; Cancellation
Activities; Proposed Collection; at the end of December 21, 2018.
AGENCY: Food and Drug Administration, Comment Request; Collection of Comments received by mail/hand
HHS. Conflict of Interest Information for delivery/courier (for written/paper
ACTION: Notice. Participation in Food and Drug submissions) will be considered timely
Administration Non-Employee if they are postmarked or the delivery
SUMMARY: The meeting of the Allergenic Fellowship and Traineeship Programs service acceptance receipt is on or
Products Advisory Committee before that date.
AGENCY: Food and Drug Administration,
scheduled for November 7, 2018, is
HHS. Electronic Submissions
cancelled. This meeting was announced
in the Federal Register of September 26, ACTION: Notice.
Submit electronic comments in the
2018. SUMMARY: The Food and Drug following way:
FOR FURTHER INFORMATION CONTACT: Administration (FDA or Agency) is • Federal eRulemaking Portal:
Serina Hunter-Thomas, Center for announcing an opportunity for public https://www.regulations.gov. Follow the
Biologics Evaluation and Research, comment on the proposed collection of instructions for submitting comments.
Food and Drug Administration, 10903 certain information by the Agency. Comments submitted electronically,
daltland on DSKBBV9HB2PROD with NOTICES
New Hampshire Ave., Bldg. 71, Rm. Under the Paperwork Reduction Act of including attachments, to https://
6338, Silver Spring, MD 20993–0002, 1995 (PRA), Federal Agencies are www.regulations.gov will be posted to
240–402–5771, serina.hunter-thomas@ required to publish notice in the the docket unchanged. Because your
fda.hhs.gov, or FDA Advisory Federal Register concerning each comment will be made public, you are
Committee Information Line, 1–800– proposed collection of information, solely responsible for ensuring that your
741–8138 (301–443–0572 in the including each proposed extension of an comment does not include any
Washington, DC area), and follow the existing collection of information, and confidential information that you or a
VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1](https://thefederalregister.org/doc/83_FR_53461/page/1.svg)
![Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53259
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
Collection Form—Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
Oak Ridge Institute for Science and Education Fellowship 500 1 500 1 500
Traineeship Program ........................................................... 500 1 500 1 500
Reagan-Udall Fellowship at FDA ........................................ 50 1 50 1 50
Total .............................................................................. ........................ ........................ ........................ ........................ 1,050
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 16, 2018. 2018. The https://www.regulations.gov Staff, FDA will post your comment, as
Leslie Kux, electronic filing system will accept well as any attachments, except for
Associate Commissioner for Policy. comments until 11:59 p.m. Eastern Time information submitted, marked and
[FR Doc. 2018–22960 Filed 10–19–18; 8:45 am] at the end of December 21, 2018. identified, as confidential, if submitted
BILLING CODE 4164–01–P Comments received by mail/hand as detailed in ‘‘Instructions.’’
delivery/courier (for written/paper Instructions: All submissions received
submissions) will be considered timely must include the Docket No. FDA–
DEPARTMENT OF HEALTH AND if they are postmarked or the delivery 2016–E–3916 for ‘‘Determination of
HUMAN SERVICES service acceptance receipt is on or Regulatory Review Period for Purposes
before that date. of Patent Extension; TECENTRIQ.’’
Food and Drug Administration Received comments, those filed in a
Electronic Submissions timely manner (see ADDRESSES), will be
[Docket No. FDA–2016–E–3916]
Submit electronic comments in the placed in the docket and, except for
Determination of Regulatory Review following way: those submitted as ‘‘Confidential
Period for Purposes of Patent • Federal eRulemaking Portal: Submissions,’’ publicly viewable at
Extension; TECENTRIQ https://www.regulations.gov. Follow the https://www.regulations.gov or at the
instructions for submitting comments. Dockets Management Staff between 9
AGENCY: Food and Drug Administration, Comments submitted electronically, a.m. and 4 p.m., Monday through
HHS. including attachments, to https:// Friday.
ACTION: Notice. www.regulations.gov will be posted to • Confidential Submissions—To
the docket unchanged. Because your submit a comment with confidential
SUMMARY: The Food and Drug information that you do not wish to be
comment will be made public, you are
Administration (FDA or the Agency) has made publicly available, submit your
solely responsible for ensuring that your
determined the regulatory review period comments only as a written/paper
comment does not include any
for TECENTRIQ and is publishing this submission. You should submit two
confidential information that you or a
notice of that determination as required copies total. One copy will include the
third party may not wish to be posted,
by law. FDA has made the information you claim to be confidential
such as medical information, your or
determination because of the with a heading or cover note that states
anyone else’s Social Security number, or
submission of an application to the ‘‘THIS DOCUMENT CONTAINS
confidential business information, such
Director of the U.S. Patent and CONFIDENTIAL INFORMATION.’’ The
as a manufacturing process. Please note
Trademark Office (USPTO), Department Agency will review this copy, including
that if you include your name, contact
of Commerce, for the extension of a the claimed confidential information, in
information, or other information that
patent which claims that human its consideration of comments. The
identifies you in the body of your
biological product. second copy, which will have the
comments, that information will be
DATES: Anyone with knowledge that any claimed confidential information
posted on https://www.regulations.gov.
of the dates as published (see the • If you want to submit a comment redacted/blacked out, will be available
SUPPLEMENTARY INFORMATION section) are with confidential information that you for public viewing and posted on
incorrect may submit either electronic do not wish to be made available to the https://www.regulations.gov. Submit
or written comments and ask for a public, submit the comment as a both copies to the Dockets Management
redetermination by December 21, 2018. written/paper submission and in the Staff. If you do not wish your name and
Furthermore, any interested person may manner detailed (see ‘‘Written/Paper contact information to be made publicly
petition FDA for a determination Submissions’’ and ‘‘Instructions’’). available, you can provide this
regarding whether the applicant for information on the cover sheet and not
extension acted with due diligence Written/Paper Submissions in the body of your comments and you
during the regulatory review period by Submit written/paper submissions as must identify this information as
April 22, 2019. See ‘‘Petitions’’ in the follows: ‘‘confidential.’’ Any information marked
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION section for • Mail/Hand delivery/Courier (for as ‘‘confidential’’ will not be disclosed
more information. written/paper submissions): Dockets except in accordance with § 10.20 (21
ADDRESSES: You may submit comments Management Staff (HFA–305), Food and CFR 10.20) and other applicable
as follows. Please note that late, Drug Administration, 5630 Fishers disclosure law. For more information
untimely filed comments will not be Lane, Rm. 1061, Rockville, MD 20852. about FDA’s posting of comments to
considered. Electronic comments must • For written/paper comments public dockets, see 80 FR 56469,
be submitted on or before December 21, submitted to the Dockets Management September 18, 2015, or access the
VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1](https://thefederalregister.org/doc/83_FR_53461/page/3.svg)
Document Created: 2018-10-20 01:49:49
Document Modified: 2018-10-20 01:49:49
| 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 21, 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 53257 |
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