83 FR 26698 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26698-26699 | |
| FR Document | 2018-12338 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26698-26699] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12338] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0231; FDA-2014-N-0996; FDA-2010-N-0161; FDA- 2017-N-5624; FDA-2011-N-0085; FDA-2013-D-0575; and FDA-2016-N-3710] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required [[Page 26699]] to respond to, a collection of information unless it displays a currently valid OMB control number. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Biological Products--General Records and 0910-0308 4/30/2021 Postmarket Adverse Experience Reporting Guidance for Industry: Fast Track, Drug 0910-0389 4/30/2021 Development Programs--Designation, Development, and Application Review.... Export Certificates for FDA Regulated 0910-0498 4/30/2021 Products under U.S.C. Sections 801(e) and 802................................ Content and Format of Labeling for Human 0910-0624 4/30/2021 Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling..................... Guidance for Industry: Cooperative 0910-0629 4/30/2021 Manufacturing Arrangements for Licensed Biologics.............................. Guidance of Industry: Expedited Programs 0910-0765 4/30/2021 for Serious Conditions--Drugs and Biologics.............................. Evaluation of the Food and Drug 0910-0851 4/30/2021 Administration's Point-of-Sale Campaign ------------------------------------------------------------------------ Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12338 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
![26698 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
ADDRESSES: You may submit comments Received comments, those filed in a regarding the potential for illicit trade
as follows. Please note that late, timely manner (see ADDRESSES), will be markets to develop in response to a
untimely filed comments will not be placed in the docket and, except for tobacco product standard. The Agency
considered. Electronic comments must those submitted as ‘‘Confidential received a request for a 90-day
be submitted on or before July 16, 2018. Submissions,’’ publicly viewable at extension of the comment period for the
The https://www.regulations.gov https://www.regulations.gov or at the NOA. The request conveyed concern
electronic filing system will accept Dockets Management Staff between 9 that the current 90-day comment period
comments until midnight Eastern Time a.m. and 4 p.m., Monday through does not allow sufficient time to
at the end of July 16, 2018. Comments Friday. develop a meaningful or thoughtful
received by mail/hand delivery/courier • Confidential Submissions—To response to the NOA.
(for written/paper submissions) will be submit a comment with confidential FDA has considered the request and
considered timely if they are information that you do not wish to be is extending the comment period for the
postmarked or the delivery service made publicly available, submit your NOA for 30 days, until July 16, 2018.
acceptance receipt is on or before that comments only as a written/paper The Agency believes that a 30-day
date. submission. You should submit two extension allows adequate time for
copies total. One copy will include the interested persons to submit comments
Electronic Submissions information you claim to be confidential without creating significant delay.
Submit electronic comments in the with a heading or cover note that states Dated: June 5, 2018.
following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: Leslie Kux,
CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including Associate Commissioner for Policy.
instructions for submitting comments. the claimed confidential information, in [FR Doc. 2018–12370 Filed 6–7–18; 8:45 am]
Comments submitted electronically, its consideration of comments. The BILLING CODE 4164–01–P
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available DEPARTMENT OF HEALTH AND
comment will be made public, you are for public viewing and posted on HUMAN SERVICES
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any Food and Drug Administration
both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and [Docket Nos. FDA–2011–N–0231; FDA–
third party may not wish to be posted, contact information to be made publicly 2014–N–0996; FDA–2010–N–0161; FDA–
such as medical information, your or available, you can provide this 2017–N–5624; FDA–2011–N–0085; FDA–
anyone else’s Social Security number, or 2013–D–0575; and FDA–2016–N–3710]
information on the cover sheet and not
confidential business information, such in the body of your comments and you Agency Information Collection
as a manufacturing process. Please note must identify this information as Activities; Announcement of Office of
that if you include your name, contact ‘‘confidential.’’ Any information marked Management and Budget Approvals
information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20 AGENCY: Food and Drug Administration,
comments, that information will be and other applicable disclosure law. For HHS.
posted on https://www.regulations.gov. more information about FDA’s posting ACTION: Notice.
• If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access SUMMARY: The Food and Drug
do not wish to be made available to the the information at: https://www.gpo.gov/ Administration (FDA) is publishing a
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- list of information collections that have
written/paper submission and in the 23389.pdf. been approved by the Office of
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Management and Budget (OMB) under
Submissions’’ and ‘‘Instructions’’). read background documents or the the Paperwork Reduction Act of 1995.
Written/Paper Submissions electronic and written/paper comments FOR FURTHER INFORMATION CONTACT: Ila
received, go to https:// S. Mizrachi, Office of Operations, Food
Submit written/paper submissions as www.regulations.gov and insert the and Drug Administration, Three White
follows: docket number, found in brackets in the Flint North, 10A–12M, 11601
• Mail/Hand delivery/Courier (for heading of this document, into the Landsdown St., North Bethesda, MD
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts 20852, 301–796–7726, PRAStaff@
Management Staff (HFA–305), Food and and/or go to the Dockets Management fda.hhs.gov.
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. SUPPLEMENTARY INFORMATION: The
Rockville, MD 20852.
• For written/paper comments following is a list of FDA information
FOR FURTHER INFORMATION CONTACT: collections recently approved by OMB
submitted to the Dockets Management
Staff, FDA will post your comment, as Christopher Griffiths or Nate Mease, under section 3507 of the Paperwork
well as any attachments, except for Center for Tobacco Products, Food and Reduction Act of 1995 (44 U.S.C. 3507).
information submitted, marked and Drug Administration, 10903 New The OMB control number and
identified, as confidential, if submitted Hampshire Ave., Silver Spring, MD expiration date of OMB approval for
amozie on DSK3GDR082PROD with NOTICES1
as detailed in ‘‘Instructions.’’ 20993, 1–877–287–1373, AskCTP@ each information collection are shown
Instructions: All submissions received fda.hhs.gov. in table 1. Copies of the supporting
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: In the statements for the information
2018–N–0529 for ‘‘Draft Concept Paper: Federal Register of March 16, 2018, collections are available on the internet
Illicit Trade in Tobacco Products after FDA published an NOA with a 90-day at https://www.reginfo.gov/public/do/
Implementation of a Food and Drug comment period to request public PRAMain. An Agency may not conduct
Administration Product Standard.’’ comment on the draft concept paper or sponsor, and a person is not required
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![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26699
to respond to, a collection of information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
Biological Products—General Records and Postmarket Adverse Experience Reporting ...................................... 0910–0308 4/30/2021
Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application
Review .................................................................................................................................................................. 0910–0389 4/30/2021
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 ..................................... 0910–0498 4/30/2021
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy
and Lactation Labeling ......................................................................................................................................... 0910–0624 4/30/2021
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics .................................... 0910–0629 4/30/2021
Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics ................................... 0910–0765 4/30/2021
Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign .......................................................... 0910–0851 4/30/2021
Dated: June 4, 2018. at the end of August 7, 2018. Comments Staff, FDA will post your comment, as
Leslie Kux, received by mail/hand delivery/courier well as any attachments, except for
Associate Commissioner for Policy. (for written/paper submissions) will be information submitted, marked and
[FR Doc. 2018–12338 Filed 6–7–18; 8:45 am] considered timely if they are identified, as confidential, if submitted
BILLING CODE 4164–01–P postmarked or the delivery service as detailed in ‘‘Instructions.’’
acceptance receipt is on or before that Instructions: All submissions received
date. must include the Docket No. FDA–
DEPARTMENT OF HEALTH AND 2009–N–0232 for ‘‘Agency Information
Electronic Submissions Collection Activities; Proposed
HUMAN SERVICES
Submit electronic comments in the Collection; Comment Request; Interstate
Food and Drug Administration following way: Shellfish Dealer’s Certificate.’’ Received
• Federal eRulemaking Portal: comments, those filed in a timely
[Docket No. FDA–2009–N–0232]
https://www.regulations.gov. Follow the manner (see ADDRESSES), will be placed
Agency Information Collection instructions for submitting comments. in the docket and, except for those
Activities; Proposed Collection; Comments submitted electronically, submitted as ‘‘Confidential
Comment Request; Interstate Shellfish including attachments, to https:// Submissions,’’ publicly viewable at
Dealer’s Certificate www.regulations.gov will be posted to https://www.regulations.gov or at the
the docket unchanged. Because your Dockets Management Staff between 9
AGENCY: Food and Drug Administration, comment will be made public, you are a.m. and 4 p.m., Monday through
HHS. solely responsible for ensuring that your Friday.
ACTION: Notice. comment does not include any • Confidential Submissions—To
confidential information that you or a submit a comment with confidential
SUMMARY: The Food and Drug third party may not wish to be posted, information that you do not wish to be
Administration (FDA or Agency) is such as medical information, your or made publicly available, submit your
announcing an opportunity for public anyone else’s Social Security number, or comments only as a written/paper
comment on the proposed collection of confidential business information, such submission. You should submit two
certain information by the Agency. as a manufacturing process. Please note copies total. One copy will include the
Under the Paperwork Reduction Act of that if you include your name, contact information you claim to be confidential
1995 (PRA), Federal Agencies are information, or other information that with a heading or cover note that states
required to publish notice in the identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS
Federal Register concerning each comments, that information will be CONFIDENTIAL INFORMATION.’’ The
proposed collection of information, posted on https://www.regulations.gov. Agency will review this copy, including
including each proposed extension of an • If you want to submit a comment the claimed confidential information, in
existing collection of information, and with confidential information that you its consideration of comments. The
to allow 60 days for public comment in do not wish to be made available to the second copy, which will have the
response to the notice. This notice public, submit the comment as a claimed confidential information
solicits comments on the information written/paper submission and in the redacted/blacked out, will be available
collection provisions of the Interstate manner detailed (see ‘‘Written/Paper for public viewing and posted on
Shellfish Dealer’s Certificate. Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit
DATES: Submit either electronic or both copies to the Dockets Management
written comments on the collection of Written/Paper Submissions Staff. If you do not wish your name and
information by August 7, 2018. Submit written/paper submissions as contact information to be made publicly
ADDRESSES: You may submit comments follows: available, you can provide this
amozie on DSK3GDR082PROD with NOTICES1
as follows. Please note that late, • Mail/Hand delivery/Courier (for information on the cover sheet and not
untimely filed comments will not be written/paper submissions): Dockets in the body of your comments and you
considered. Electronic comments must Management Staff (HFA–305), Food and must identify this information as
be submitted on or before August 7, Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked
2018. The https://www.regulations.gov Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed
electronic filing system will accept • For written/paper comments except in accordance with 21 CFR 10.20
comments until midnight Eastern Time submitted to the Dockets Management and other applicable disclosure law. For
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Document Created: 2018-06-08 01:22:14
Document Modified: 2018-06-08 01:22:14
| 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. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 26698 |
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