34598 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Labeling Requirements in §§ 201.56 and 201.57 ................ 406 1.332 541 2,327 1,258,907 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Estimates may not sum due to rounding. 

Our estimated burden for the 

information collection reflects an 

overall increase of 602,503 hours and a 

corresponding increase of 345 records. 

We attribute this adjustment to an 

increase in the number of submissions 

we received over the last few years. 

Dated: July 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15512 Filed 7–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

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Considerations; Draft Guidance for 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. 

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Considerations; Draft Guidance for 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.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. 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 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, Richard.Lostritto@fda.hhs.gov. 

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/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Chris Kornak, 240–627–3705, 

chris.kornak@nih.gov. Licensing 

information and copies of the U.S. 

patent applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office (TTIPO), 5601 Fishers 

Lane, Suite 6D, MSC 9804, Rockville, 

MD 20892, tel: 301–496–2644, fax: 240– 

627–3117. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Inhibition of CD300f Function on 

Dendritic Cells Promotes Tumor 

Destruction 

Description of Technology: Cancer 

immunotherapy aims to enhance the 

ability of a patient’s own immune 

response to destroy tumors. The 

magnitude of the immune response is 

determined by the balance between 

immune activating signals and negative 

inhibitory signals. Checkpoint receptors 

are negative regulators that normally 

deliver inhibitory signals which limit 

immune activation. Blockade of 

immune checkpoints represents an 

effective strategy to enhance the 

immune response against cancer cells. 

NIAID researchers have discovered 

that blocking CD300f function in 

dendritic cells markedly enhances their 

ability to phagocytose and process 

apoptotic tumor cells, leading to 

substantial inhibition of tumor growth. 

In this light, CD300f may be viewed as 

a dendritic cell checkpoint receptor 

analogous to T cell checkpoint receptors 

like PD–1 and CTLA–4. As a result, 

inhibiting CD300f function on dendritic 

cells could be a promising anti-cancer 

therapy, especially in the settings where 

blocking of T cell checkpoint receptors 

has been ineffective. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications: 

• Cancer immunotherapy 

Competitive Advantages: 

• A novel approach 

Development Stage: 

• Pre-Clinical 

• Proof-of-concept studies in mouse 

models 

Inventors: John E. Coligan, Konrad 

Krzewski, Linjie Tian, Ha-Na Lee, all of 

NIAID, NIH. 

Publications: Tian, L. et al., Enhanced 

efferocytosis by dendritic cells underlies 

memory T-cell expansion and 

susceptibility to autoimmune disease in 

CD300f-deficient mice. Cell Death and 

Differ (2016) 23, 1086–1096. 

Intellectual Property: HHS Reference 

No. E–257–2016/0—U.S. Patent 

Application No. 62/408,596 filed on 10/ 

14/2016;—PCT/US2017/056192 filed on 

10/11/2017. 

Licensing Contact: Chris Kornak, 240– 

627–3705, Chris.Kornak@nih.gov. 

Collaborative Research Opportunity: 

The Technology Transfer and 

Intellectual Property Office (TTIPO) is 

not seeking parties interested in 

collaborative research to further develop 

the technology. 

Dated: July 9, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–15489 Filed 7–19–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Generic Clearance To 

Conduct Voluntary Customer/Partner 

Surveys (NLM) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 


daltland on DSKBBV9HB2PROD with NOTICES