82 FR 24723 - Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 102 (May 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 102 (May 30, 2017)
| Page Range | 24723-24725 | |
| FR Document | 2017-11008 |
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)] [Notices] [Pages 24723-24725] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11008] [[Page 24723]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0493] Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded 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 information associated with the criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded. DATES: Submit either electronic or written comments on the collection of information by July 31, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 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. ADDRESSES: You may submit comments as follows: 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): 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-2010-N-0493 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Criteria and Procedures for Classifying Over-the-counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded.'' Received comments, those received in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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: 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [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 [[Page 24724]] 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. Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and Not Misbranded--21 CFR 330.14; OMB Control Number 0910-0688--Revision FDA regulations at Sec. 330.14 (21 CFR 330.14) establish additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. These regulations state that OTC drug products introduced into the U.S. market after the OTC drug review began and OTC drug products without any marketing experience in the United States can be evaluated under the monograph process if the conditions (e.g., active ingredients) meet certain ``time and extent'' criteria outlined in the regulations. The regulations allow a time and extent application (TEA) to be submitted to us by any party for our consideration to include new conditions in the OTC drug monograph system. TEAs must provide evidence described in Sec. 330.14(c) demonstrating that the condition is eligible for inclusion in the monograph system. (Section 330.14(d) specifies the number of copies and address for submission of a TEA.) If a condition is found eligible, any interested parties can submit safety and effectiveness information as explained in Sec. 330.14(f). Safety and effectiveness data includes the data and information listed in Sec. 330.10(a)(2), a listing of all serious adverse drug experiences that may have occurred (Sec. 330.14(f)(2)), and an official or proposed compendial monograph (Sec. 330.14(i)). Based on our experience with submissions we have received under Sec. 330.14, we estimate that we will receive two TEAs and two safety and effectiveness submissions each year, and that it will take approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a comprehensive safety and effectiveness submission. This information is reflected in rows 1 and 2 of table 1. Recently FDA revised its regulations at 21 CFR part 330 (81 FR 84465, November 23, 2016), thus adding 6 hours to FDA's estimated annual reporting burden for the information collection. Specifically, Sec. 330.14(j) clarifies the requirements on content and format criteria for a safety and effectiveness data submission, and provides procedures for FDA's review of the submissions and determination of whether a submission is sufficiently complete to permit a substantive review. Section 330.14(j)(3) describes the process for cases in which FDA refuses to file the safety and effectiveness data submission. Under Sec. 330.14(j)(3), if FDA refuses to file the submission, the Agency will notify the sponsor in writing, state the reason(s) for the refusal, and provide the sponsor with 30 days in which to submit a written request for an informal conference with the Agency about whether the Agency should file the submission. We estimate that approximately one respondent will annually submit a request for an informal conference, and that preparing and submitting each request will take approximately 1 hour. This is reflected in row 3 of table 1. Under Sec. 330.14(j)(4)(iii), the safety and effectiveness data submission must contain a signed statement that the submission represents a complete safety and effectiveness data submission and that the submission includes all the safety and effectiveness data and information available to the sponsor at the time of the submission, whether positive or negative. We estimate that approximately two respondents annually will submit such signed statements, and that preparing and submitting each signed statement will take approximately 1 hour. This is reflected in row 4 of table 1. Under Sec. 330.14(k)(1), FDA, in response to a written request from a sponsor, may withdraw consideration of a TEA submitted under Sec. 330.14(c) or a safety and effectiveness data submission submitted under Sec. 330.14(f). We estimate that approximately one respondent will annually submit such a request, and that preparing and submitting the request will take approximately 1 hour. This is reflected in row 5 of table 1. Under Sec. 330.14(k)(2), a sponsor may request that FDA not withdraw consideration of a TEA or safety and effectiveness data submission. We estimate one respondent will annually submit such a request, and that preparing and submitting the request will take approximately 2 hours. This is reflected in row 6 of table 1. Accordingly, FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR part 330; activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 330.14(c) and (d); Time and 2 1 2 1,525 3,050 extent application and submission of information...... 330.14(f) and (i); Safety and 2 1 2 2,350 4,700 effectiveness data............. 330.14(j)(3); sponsor request 1 1 1 1 1 for informal conference........ 330.14(j)(4); sponsor signed 2 1 2 1 2 statement that submission is complete....................... 330.14(k)(l); sponsor request 1 1 1 1 1 for FDA withdraw of TEA consideration.................. 330.14(k)(2); sponsor request 1 1 1 2 2 for FDA to not deem submission withdrawn...................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 7,756 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 24725]] Dated: May 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11008 Filed 5-26-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 24723
DEPARTMENT OF HEALTH AND comment does not include any claimed confidential information
HUMAN SERVICES confidential information that you or a redacted/blacked out, will be available
third party may not wish to be posted, for public viewing and posted on
Food and Drug Administration such as medical information, your or https://www.regulations.gov. Submit
[Docket No. FDA–2010–N–0493] anyone else’s Social Security number, or both copies to the Division of Dockets
confidential business information, such Management. If you do not wish your
Agency Information Collection as a manufacturing process. Please note name and contact information to be
Activities; Proposed Collection; that if you include your name, contact made publicly available, you can
Comment Request; Additional Criteria information, or other information that provide this information on the cover
and Procedures for Classifying Over- identifies you in the body of your sheet and not in the body of your
the-Counter Drugs as Generally comments, that information will be comments and you must identify this
Recognized as Safe and Effective and posted on https://www.regulations.gov. information as ‘‘confidential.’’ Any
Not Misbranded • If you want to submit a comment information marked as ‘‘confidential’’
with confidential information that you will not be disclosed except in
AGENCY: Food and Drug Administration, do not wish to be made available to the accordance with 21 CFR 10.20 and other
HHS. public, submit the comment as a applicable disclosure law. For more
ACTION: Notice. written/paper submission and in the information about FDA’s posting of
manner detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
SUMMARY: The Food and Drug
Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
Administration (FDA or Agency) is
announcing an opportunity for public Written/Paper Submissions the information at: https://www.gpo.gov/
comment on the proposed collection of fdsys/pkg/FR-2015-09-18/pdf/2015-
Submit written/paper submissions as 23389.pdf.
certain information by the Agency. follows: Docket: For access to the docket to
Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for
1995 (PRA), Federal Agencies are read background documents or the
written/paper submissions): Division of
required to publish notice in the electronic and written/paper comments
Dockets Management (HFA–305), Food
Federal Register concerning each received, go to https://
and Drug Administration, 5630 Fishers
proposed collection of information, www.regulations.gov and insert the
Lane, Rm. 1061, Rockville, MD 20852.
including each proposed extension of an • For written/paper comments docket number, found in brackets in the
existing collection of information, and submitted to the Division of Dockets heading of this document, into the
to allow 60 days for public comment in Management, FDA will post your ‘‘Search’’ box and follow the prompts
response to the notice. This notice comment, as well as any attachments, and/or go to the Division of Dockets
solicits comments on the collection of except for information submitted, Management, 5630 Fishers Lane, Rm.
information associated with the criteria marked and identified, as confidential, 1061, Rockville, MD 20852.
and procedures for classifying over-the- if submitted as detailed in FOR FURTHER INFORMATION CONTACT:
counter (OTC) drugs as generally ‘‘Instructions.’’ JonnaLynn Capezzuto, Office of
recognized as safe and effective and not Instructions: All submissions received Operations, Food and Drug
misbranded. must include the Docket No. FDA– Administration, Three White Flint
DATES: Submit either electronic or 2010–N–0493 for ‘‘Agency Information North, 10A63, 11601 Landsdown St.,
written comments on the collection of Collection Activities; Proposed North Bethesda, MD 20852, 301–796–
information by July 31, 2017. Late, Collection; Comment Request; 3794, PRAStaff@fda.hhs.gov.
untimely filed comments will not be Additional Criteria and Procedures for SUPPLEMENTARY INFORMATION: Under the
considered. Electronic comments must Classifying Over-the-counter Drugs as PRA (44 U.S.C. 3501–3520), Federal
be submitted on or before July 31, 2017. Generally Recognized as Safe and Agencies must obtain approval from the
The https://www.regulations.gov Effective and Not Misbranded.’’ Office of Management and Budget
electronic filing system will accept Received comments, those received in a (OMB) for each collection of
comments until midnight Eastern Time timely manner (see DATES), will be information they conduct or sponsor.
at the end of July 31, 2017. Comments placed in the docket and, except for ‘‘Collection of information’’ is defined
received by mail/hand delivery/courier those submitted as ‘‘Confidential in 44 U.S.C. 3502(3) and 5 CFR
(for written/paper submissions) will be Submissions,’’ publicly viewable at 1320.3(c) and includes Agency requests
considered timely if they are https://www.regulations.gov or at the or requirements that members of the
postmarked or the delivery service Division of Dockets Management public submit reports, keep records, or
acceptance receipt is on or before that between 9 a.m. and 4 p.m., Monday provide information to a third party.
date. through Friday. Section 3506(c)(2)(A) of the PRA (44
ADDRESSES: You may submit comments • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal
as follows: submit a comment with confidential Agencies to provide a 60-day notice in
information that you do not wish to be the Federal Register concerning each
Electronic Submissions made publicly available, submit your proposed collection of information,
Submit electronic comments in the comments only as a written/paper including each proposed extension of an
following way: submission. You should submit two existing collection of information,
• Federal eRulemaking Portal: copies total. One copy will include the before submitting the collection to OMB
https://www.regulations.gov. Follow the information you claim to be confidential
sradovich on DSK3GMQ082PROD with NOTICES
for approval. To comply with this
instructions for submitting comments. with a heading or cover note that states requirement, FDA is publishing notice
Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS of the proposed collection of
including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The information set forth in this document.
www.regulations.gov will be posted to Agency will review this copy, including With respect to the following
the docket unchanged. Because your the claimed confidential information, in collection of information, FDA invites
comment will be made public, you are its consideration of comments. The comments on these topics: (1) Whether
solely responsible for ensuring that your second copy, which will have the the proposed collection of information
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![Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 24725
Dated: May 23, 2017. Neurosciences, National Institutes of Health, DEPARTMENT OF HEALTH AND
Anna K. Abram, HHS) HUMAN SERVICES
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. Dated: May 24, 2017. National Institutes of Health
[FR Doc. 2017–11008 Filed 5–26–17; 8:45 am] Sylvia L. Neal,
Program Analyst, Office of Federal Advisory National Heart, Lung, and Blood
BILLING CODE 4164–01–P
Committee Policy. Institute; Notice of Closed Meetings
[FR Doc. 2017–11097 Filed 5–26–17; 8:45 am] Pursuant to section 10(d) of the
DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P Federal Advisory Committee Act, as
HUMAN SERVICES amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
National Institutes of Health DEPARTMENT OF HEALTH AND The meetings will be closed to the
National Institute of Neurological HUMAN SERVICES public in accordance with the
Disorders and Stroke; Notice of Closed provisions set forth in sections
National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Meetings
as amended. The grant applications and
Pursuant to section 10(d) of the National Heart, Lung, and Blood the discussions could disclose
Federal Advisory Committee Act, as Institute Notice of Closed Meeting confidential trade secrets or commercial
amended (5 U.S.C. App.), notice is property such as patentable material,
hereby given of the following meetings. Pursuant to section 10(d) of the and personal information concerning
The meetings will be closed to the Federal Advisory Committee Act, as individuals associated with the grant
public in accordance with the amended (5 U.S.C. App.), notice is applications, the disclosure of which
provisions set forth in sections hereby given of the following meeting. would constitute a clearly unwarranted
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the invasion of personal privacy.
as amended. The grant applications and public in accordance with the Name of Committee: National Heart, Lung,
the discussions could disclose provisions set forth in sections and Blood Institute Special Emphasis Panel;
confidential trade secrets or commercial Cardiovascular and Pulmonary Research on
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
property such as patentable material, E-Cigarettes.
as amended. The grant applications and
and personal information concerning Date: June 20, 2017.
the discussions could disclose
individuals associated with the grant Time: 8:00 a.m. to 4:00 p.m.
applications, the disclosure of which confidential trade secrets or commercial Agenda: To review and evaluate grant
would constitute a clearly unwarranted property such as patentable material, applications.
invasion of personal privacy. and personal information concerning Place: The Westin Crystal City, 1800
individuals associated with the grant Jefferson Davis Highway, Arlington, VA
Name of Committee: National Institute of 22202.
Neurological Disorders and Stroke Initial
applications, the disclosure of which
would constitute a clearly unwarranted Contact Person: David A. Wilson, Ph.D.,
Review Group; Neurological Sciences and Scientific Review Officer, Office of Scientific
Disorders B. invasion of personal privacy. Review/DERA, National Heart, Lung, and
Date: June 22–23, 2017. Name of Committee: Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room
Time: 8:00 a.m. to 6:00 p.m. Blood Initial Review Group; NHLBI 7204, Bethesda, MD 20892–7924, 301–827–
Agenda: To review and evaluate grant 7993, wilsonda2@nhlbi.nih.gov.
Mentored Clinical and Basic Science Review
applications.
Committee. Name of Committee: National Heart, Lung,
Place: Wyndham Grand Chicago Riverfront
Date: June 22–23, 2017. and Blood Institute Special Emphasis Panel;
Hotel, 71 East Wacker Drive, Chicago, IL
Time: 10:30 a.m. to 3:00 p.m. Grant Review for NHLBI K Award Recipients.
60601.
Agenda: To review and evaluate grant Date: June 20, 2017.
Contact Person: Birgit Neuhuber, Ph.D.,
Time: 1:00 p.m. to 4:00 p.m.
Scientific Review Officer , Scientific Review applications.
Agenda: To review and evaluate grant
Branch, NINDS/NIH/DHHS, Neuroscience Place: The Westin Crystal City, 1800 applications.
Center, 6001 Executive Blvd., Suite 3204, Jefferson Davis Highway, Arlington, VA Place: National Institutes of Health, 6701
MSC 9529, (301) 496–9223, Bethesda, MD 22202. Rockledge Drive, Room 7202, Bethesda, MD
20892–9529, neuhuber@ninds.nih.gov. Contact Person: Keith A. Mintzer, Ph.D., 20892 (Telephone Conference Call).
Name of Committee: National Institute of Scientific Review Officer, Office of Scientific Contact Person: Melissa E. Nagelin, Ph.D.,
Neurological Disorders and Stroke Special Review/DERA, National Heart, Lung, and Scientific Review Officer, Office of Scientific
Emphasis Panel; R13 Review. Blood Institute, 6701 Rockledge Drive, Room Review/DERA, National Heart, Lung, and
Date: June 22, 2017. Blood Institute, 6701 Rockledge Drive, Room
7186, Bethesda, MD 20892–7924, 301–827–
Time: 9:00 a.m. to 5:00 p.m. 7202, Bethesda, MD 20892, 301–594–8518,
7949, mintzerk@nhlbi.nih.gov.
Agenda: To review and evaluate grant nagelinmh2@nhlbi.nih.gov.
applications. (Catalogue of Federal Domestic Assistance Name of Committee: National Heart, Lung,
Place: National Institutes of Health, Program Nos. 93.233, National Center for and Blood Institute Special Emphasis Panel;
Neuroscience Center, 6001 Executive Sleep Disorders Research; 93.837, Heart and Single-Site Clinical Trial Applications.
Boulevard, Rockville, MD 20852 (Virtual Vascular Diseases Research; 93.838, Lung Date: June 21, 2017.
Meeting). Diseases Research; 93.839, Blood Diseases Time: 8:00 a.m. to 3:00 p.m.
Contact Person: Ernest Lyons, Ph.D.,
and Resources Research, National Institutes Agenda: To review and evaluate grant
Scientific Review Officer, Scientific Review
of Health, HHS) applications.
sradovich on DSK3GMQ082PROD with NOTICES
Branch, NINDS/NIH/DHHS, Neuroscience
Place: Residence Inn Bethesda, 7335
Center, 6001 Executive Blvd., Suite 3204, Dated: May 23, 2017. Wisconsin Avenue, Bethesda, MD 20814.
MSC 9529, Bethesda, MD 20892–9529, (301)
Michelle Trout, Contact Person: Chang Sook Kim, Ph.D.,
496–4056, lyonse@ninds.nih.gov.
Program Analyst, Office of Federal Advisory Scientific Review Officer, Office of Scientific
(Catalogue of Federal Domestic Assistance Committee Policy. Review/DERA, National Heart, Lung, and
Program Nos. 93.853, Clinical Research Blood Institute, 6701 Rockledge Drive, Room
[FR Doc. 2017–10994 Filed 5–26–17; 8:45 am]
Related to Neurological Disorders; 93.854, 7188, Bethesda, MD 20892–7924, 301–827–
Biological Basis Research in the BILLING CODE 4140–01–P 7940, carolko@mail.nih.gov.
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Document Created: 2018-11-08 08:54:44
Document Modified: 2018-11-08 08:54:44
| 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 July 31, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 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. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 82 FR 24723 |
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