Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability; Reopening of Comment Period, 27130-27131 [2019-12292]

Download as PDF 27130 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices 209092 was approved on March 13, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 879 days, 22 days, 292 days, 459 days, or 204 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12305 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKBBV9HB2PROD with NOTICES [Docket No. FDA–2019–D–0298] Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of comment period. ACTION: VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ‘‘Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability’’ that appeared in the Federal Register of February 27, 2019. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period for the notice published on February 27, 2019 (84 FR 6403). Submit either electronic or written comments on the draft guidance by August 12, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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.’’ PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the Docket No. FDA– 2019–D–0298 for ‘‘Quality Considerations for Continuous Manufacturing.’’ Received comments 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– E:\FR\FM\11JNN1.SGM 11JNN1 27131 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Sau L. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993–0002, 301–796–2905. FOR FURTHER INFORMATION CONTACT: SUMMARY: Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12292 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: 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. II. Electronic Access 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, PRAStaff@ fda.hhs.gov. 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 http://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 27, 2019, FDA published a notice with a 90-day comment period to request comments on the draft guidance for industry entitled ‘‘Quality Considerations for Continuous Manufacturing.’’ FDA is reopening the comment period until August 12, 2019. The Agency believes that an additional 60 days will allow adequate time for interested persons to submit comments without compromising the timely publication of the final version of the guidance. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–N–0215; FDA– 2012–N–0248; FDA–2015–N–2126; FDA– 2012–N–0280; FDA–2012–N–1093; FDA– 2018–N–4130; and FDA–2011–N–0143] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Healthcare Professional Survey of Professional Prescription Drug Promotion ...................................................... Formal Dispute Resolutions; Appeals Above the Division Level ............................................................................ Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco Among LGBT (RESPECT) ........................................................................................................................ Financial Disclosure by Clinical Investigators ......................................................................................................... Food Additive Petitions and Investigational Food Additive Exemptions ................................................................. Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water ............... Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ...................................... Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12278 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKBBV9HB2PROD with NOTICES 17:36 Jun 10, 2019 Jkt 247001 To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All ADDRESSES: Food and Drug Administration, VerDate Sep<11>2014 The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Fax written comments on the collection of information by July 11, 2019. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration HHS. Notice. DATES: [Docket No. FDA–2013–N–1425] AGENCY: ACTION: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Date approval expires 0910–0869 0910–0430 4/30/2020 3/31/2022 0910–0808 0910–0396 0910–0546 0910–0658 0910–0752 3/31/2022 4/30/2022 4/30/2022 4/30/2022 4/30/2022 comments should be identified with the OMB control number 0910–0812. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27130-27131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12292]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0298]


Quality Considerations for Continuous Manufacturing; Draft 
Guidance for Industry; Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice entitled ``Quality 
Considerations for Continuous Manufacturing; Draft Guidance for 
Industry; Availability'' that appeared in the Federal Register of 
February 27, 2019. The Agency is taking this action to allow interested 
persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on 
February 27, 2019 (84 FR 6403). Submit either electronic or written 
comments on the draft guidance by August 12, 2019 to ensure that the 
Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): 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-2019-D-0298 for ``Quality Considerations for Continuous 
Manufacturing.'' Received comments 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.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-

[[Page 27131]]

0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 301-796-2905.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 2019, FDA published a 
notice with a 90-day comment period to request comments on the draft 
guidance for industry entitled ``Quality Considerations for Continuous 
Manufacturing.'' FDA is reopening the comment period until August 12, 
2019. The Agency believes that an additional 60 days will allow 
adequate time for interested persons to submit comments without 
compromising the timely publication of the final version of the 
guidance.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12292 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P