83_FR_34738 83 FR 34598 - Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Reopening of the Comment Period

83 FR 34598 - Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 140 (July 20, 2018)

Page Range34598-34599
FR Document2018-15508

The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the ``Metered Dose Inhaler and Dry Powder Inhaler Drug Products--Quality Considerations; Draft Guidance for Industry,'' published in the Federal Register of April 19, 2018. FDA is reopening the comment period to allow interested persons additional time to submit comments.

Federal Register, Volume 83 Issue 140 (Friday, July 20, 2018) 
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34598-34599]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1098]


Metered Dose Inhaler and Dry Powder Inhaler Drug Products--
Quality Considerations; Draft Guidance for Industry; Reopening of the 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
reopening the comment period for the ``Metered Dose Inhaler and Dry 
Powder Inhaler Drug Products--Quality Considerations; Draft Guidance 
for Industry,'' published in the Federal Register of April 19, 2018. 
FDA is reopening the comment period to allow interested persons 
additional time to submit comments.

DATES: FDA is reopening the comment period on the notice published 
April 19, 2018 (83 FR 17420). Submit either electronic or written 
comments by September 18, 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 September 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 18, 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 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-D-1098 for ``Metered Dose Inhaler and Dry Powder Inhaler Drug 
Products--Quality Considerations; Draft Guidance for Industry.'' 
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.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for

[[Page 34599]]

Drug Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002; or Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
the office in processing your requests. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Richard Lostritto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796-
1697, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of April 19, 2018 (83 FR 17420), FDA 
announced the availability of a draft guidance for industry entitled 
``Metered Dose Inhaler and Dry Powder Inhaler Drug Products--Quality 
Considerations; Draft Guidance for Industry.'' Interested persons were 
originally given until June 18, 2018, to comment on the draft guidance. 
The Agency believes that reopening the comment period for an additional 
60 days from the date of publication of this notice will allow adequate 
time for interested persons to submit comments without significantly 
delaying Agency decision making on these important issues.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15508 Filed 7-19-18; 8:45 am]
 BILLING CODE 4164-01-P

34598 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR part and activity responses per burden Total hours respondents responses respondent 2 per response Labeling Requirements in §§ 201.56 and 201.57 ................ 406 1.332 541 2,327 1,258,907 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Estimates may not sum due to rounding. Our estimated burden for the submissions) will be considered timely manner (see ADDRESSES), will be placed information collection reflects an if they are postmarked or the delivery in the docket and, except for those overall increase of 602,503 hours and a service acceptance receipt is on or submitted as ‘‘Confidential corresponding increase of 345 records. before that date. Submissions,’’ publicly viewable at We attribute this adjustment to an https://www.regulations.gov or at the Electronic Submissions increase in the number of submissions Dockets Management Staff between 9 we received over the last few years. Submit electronic comments in the a.m. and 4 p.m., Monday through following way: Friday. Dated: July 16, 2018. • Federal eRulemaking Portal: • Confidential Submissions—To Leslie Kux, https://www.regulations.gov. Follow the Associate Commissioner for Policy. submit a comment with confidential instructions for submitting comments. information that you do not wish to be [FR Doc. 2018–15512 Filed 7–19–18; 8:45 am] Comments submitted electronically, made publicly available, submit your BILLING CODE 4164–01–P including attachments, to https:// comments only as a written/paper www.regulations.gov will be posted to submission. You should submit two the docket unchanged. Because your copies total. One copy will include the DEPARTMENT OF HEALTH AND comment will be made public, you are HUMAN SERVICES information you claim to be confidential solely responsible for ensuring that your with a heading or cover note that states comment does not include any ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration confidential information that you or a CONFIDENTIAL INFORMATION.’’ The [Docket No. FDA–2018–D–1098] third party may not wish to be posted, Agency will review this copy, including such as medical information, your or the claimed confidential information, in Metered Dose Inhaler and Dry Powder anyone else’s Social Security number, or Inhaler Drug Products—Quality its consideration of comments. The confidential business information, such second copy, which will have the Considerations; Draft Guidance for as a manufacturing process. Please note Industry; Reopening of the Comment claimed confidential information that if you include your name, contact redacted/blacked out, will be available Period information, or other information that for public viewing and posted on AGENCY: Food and Drug Administration, identifies you in the body of your https://www.regulations.gov. Submit HHS. comments, that information will be both copies to the Dockets Management posted on https://www.regulations.gov. Notice; reopening of the ACTION: Staff. If you do not wish your name and • If you want to submit a comment comment period. with confidential information that you contact information to be made publicly do not wish to be made available to the available, you can provide this SUMMARY: The Food and Drug information on the cover sheet and not Administration (FDA, Agency, or we) is public, submit the comment as a written/paper submission and in the in the body of your comments and you reopening the comment period for the must identify this information as ‘‘Metered Dose Inhaler and Dry Powder manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). ‘‘confidential.’’ Any information marked Inhaler Drug Products—Quality as ‘‘confidential’’ will not be disclosed Considerations; Draft Guidance for Written/Paper Submissions except in accordance with 21 CFR 10.20 Industry,’’ published in the Federal and other applicable disclosure law. For Submit written/paper submissions as Register of April 19, 2018. FDA is more information about FDA’s posting follows: reopening the comment period to allow • Mail/Hand delivery/Courier (for of comments to public dockets, see 80 interested persons additional time to written/paper submissions): Dockets FR 56469, September 18, 2015, or access submit comments. Management Staff (HFA–305), Food and the information at: https://www.gpo.gov/ DATES: FDA is reopening the comment Drug Administration, 5630 Fishers fdsys/pkg/FR-2015-09-18/pdf/2015- period on the notice published April 19, Lane, Rm. 1061, Rockville, MD 20852. 23389.pdf. 2018 (83 FR 17420). Submit either • For written/paper comments Docket: For access to the docket to electronic or written comments by submitted to the Dockets Management read background documents or the September 18, 2018. Staff, FDA will post your comment, as electronic and written/paper comments ADDRESSES: You may submit comments well as any attachments, except for received, go to https:// as follows. Please note that late, information submitted, marked and www.regulations.gov and insert the untimely filed comments will not be identified, as confidential, if submitted docket number, found in brackets in the considered. Electronic comments must as detailed in ‘‘Instructions.’’ heading of this document, into the daltland on DSKBBV9HB2PROD with NOTICES be submitted on or before September 18, Instructions: All submissions received ‘‘Search’’ box and follow the prompts 2018. The https://www.regulations.gov must include the Docket No. FDA– and/or go to the Dockets Management electronic filing system will accept 2018–D–1098 for ‘‘Metered Dose Inhaler Staff, 5630 Fishers Lane, Rm. 1061, comments until midnight Eastern Time and Dry Powder Inhaler Drug Rockville, MD 20852. at the end of September 18, 2018. Products—Quality Considerations; Draft Submit written requests for single Comments received by mail/hand Guidance for Industry.’’ Received copies of the draft guidance to the delivery/courier (for written/paper comments, those filed in a timely Division of Drug Information, Center for VerDate Sep<11>2014 18:06 Jul 19, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1

Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34599 Drug Evaluation and Research, Food DEPARTMENT OF HEALTH AND cells could be a promising anti-cancer and Drug Administration, 10001 New HUMAN SERVICES therapy, especially in the settings where Hampshire Ave., Hillandale Building, blocking of T cell checkpoint receptors 4th Floor, Silver Spring, MD 20993– National Institutes of Health has been ineffective. 0002; or Office of Communication, This technology is available for Government-Owned Inventions; licensing for commercial development Outreach and Development, Center for Availability for Licensing in accordance with 35 U.S.C. 209 and 37 Biologics Evaluation and Research, Food and Drug Administration, 10903 AGENCY: National Institutes of Health, CFR part 404, as well as for further New Hampshire Ave., Bldg. 71, Rm. HHS. development and evaluation under a 3128, Silver Spring, MD 20993–0002. research collaboration. ACTION: Notice. Potential Commercial Applications: Send one self-addressed adhesive label to assist the office in processing your SUMMARY: The inventions listed below • Cancer immunotherapy requests. The draft guidance may also be are owned by an agency of the U.S. Competitive Advantages: obtained by mail by calling CBER at 1– Government and are available for • A novel approach licensing to achieve expeditious 800–835–4709 or 240–402–8010. See Development Stage: commercialization of results of the SUPPLEMENTARY INFORMATION section federally-funded research and • Pre-Clinical for electronic access to the draft development. Foreign patent • Proof-of-concept studies in mouse guidance document. applications are filed on selected models FOR FURTHER INFORMATION CONTACT: inventions to extend market coverage Inventors: John E. Coligan, Konrad Richard Lostritto, Center for Drug for companies and may also be available Krzewski, Linjie Tian, Ha-Na Lee, all of Evaluation and Research, Food and for licensing. NIAID, NIH. Drug Administration, 10903 New FOR FURTHER INFORMATION CONTACT: Publications: Tian, L. et al., Enhanced Hampshire Ave., Bldg. 51, Rm. 4132, Chris Kornak, 240–627–3705, efferocytosis by dendritic cells underlies Silver Spring, MD 20993, 301–796– chris.kornak@nih.gov. Licensing memory T-cell expansion and information and copies of the U.S. susceptibility to autoimmune disease in 1697, Richard.Lostritto@fda.hhs.gov. patent applications listed below may be CD300f-deficient mice. Cell Death and SUPPLEMENTARY INFORMATION: obtained by communicating with the Differ (2016) 23, 1086–1096. indicated licensing contact at the Intellectual Property: HHS Reference I. Background No. E–257–2016/0—U.S. Patent Technology Transfer and Intellectual In the Federal Register of April 19, Property Office (TTIPO), 5601 Fishers Application No. 62/408,596 filed on 10/ 2018 (83 FR 17420), FDA announced the Lane, Suite 6D, MSC 9804, Rockville, 14/2016;—PCT/US2017/056192 filed on availability of a draft guidance for MD 20892, tel: 301–496–2644, fax: 240– 10/11/2017. 627–3117. A signed Confidential Licensing Contact: Chris Kornak, 240– industry entitled ‘‘Metered Dose Inhaler Disclosure Agreement will be required 627–3705, Chris.Kornak@nih.gov. and Dry Powder Inhaler Drug Collaborative Research Opportunity: Products—Quality Considerations; Draft to receive copies of unpublished patent applications. The Technology Transfer and Guidance for Industry.’’ Interested Intellectual Property Office (TTIPO) is persons were originally given until June SUPPLEMENTARY INFORMATION: not seeking parties interested in 18, 2018, to comment on the draft Technology description follows. collaborative research to further develop guidance. The Agency believes that Inhibition of CD300f Function on the technology. reopening the comment period for an Dendritic Cells Promotes Tumor Dated: July 9, 2018. additional 60 days from the date of Destruction Suzanne M. Frisbie, publication of this notice will allow Description of Technology: Cancer Deputy Director, Technology Transfer and adequate time for interested persons to immunotherapy aims to enhance the Intellectual Property Office, National Institute submit comments without significantly ability of a patient’s own immune of Allergy and Infectious Diseases. delaying Agency decision making on response to destroy tumors. The [FR Doc. 2018–15489 Filed 7–19–18; 8:45 am] these important issues. magnitude of the immune response is BILLING CODE 4140–01–P II. Electronic Access determined by the balance between immune activating signals and negative Persons with access to the internet inhibitory signals. Checkpoint receptors DEPARTMENT OF HEALTH AND may obtain the draft guidance at https:// are negative regulators that normally HUMAN SERVICES www.fda.gov/Drugs/Guidance deliver inhibitory signals which limit ComplianceRegulatoryInformation/ immune activation. Blockade of National Institutes of Health Guidances/default.htm, https:// immune checkpoints represents an effective strategy to enhance the Proposed Collection; 60-Day Comment www.fda.gov/BiologicsBloodVaccines/ Request; Generic Clearance To GuidanceComplianceRegulatory immune response against cancer cells. NIAID researchers have discovered Conduct Voluntary Customer/Partner Information/default.htm, or https:// Surveys (NLM) www.regulations.gov. that blocking CD300f function in dendritic cells markedly enhances their AGENCY: National Institutes of Health, Dated: July 16, 2018. ability to phagocytose and process HHS. daltland on DSKBBV9HB2PROD with NOTICES Leslie Kux, apoptotic tumor cells, leading to ACTION: Notice. Associate Commissioner for Policy. substantial inhibition of tumor growth. [FR Doc. 2018–15508 Filed 7–19–18; 8:45 am] In this light, CD300f may be viewed as SUMMARY: In compliance with the BILLING CODE 4164–01–P a dendritic cell checkpoint receptor requirement of the Paperwork analogous to T cell checkpoint receptors Reduction Act of 1995 to provide like PD–1 and CTLA–4. As a result, opportunity for public comment on inhibiting CD300f function on dendritic proposed data collection projects, the VerDate Sep<11>2014 18:06 Jul 19, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1


Document Created: 2018-07-20 01:18:38
Document Modified: 2018-07-20 01:18:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; reopening of the comment period.
DatesFDA is reopening the comment period on the notice published April 19, 2018 (83 FR 17420). Submit either electronic or written comments by September 18, 2018.
ContactRichard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796- 1697, [email protected]
FR Citation83 FR 34598 
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