27614 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). We note that the information 

collected under the underlying CGMP 

regulations for drugs, devices, and 

biological products, including current 

good tissue practices for HCT/Ps, found 

in parts 211, 820, 600 through 680, and 

1271, have already been approved and 

are in effect. The provisions of part 211 

are approved under the OMB control 

number 0910–0139. The provisions of 

part 820 are approved under OMB 

control number 0910–0073. The 

provisions of parts 606 and 640 are 

approved under OMB control number 

0910–0116. The provisions of part 610 

are approved under OMB control 

number 0910–0116 and OMB control 

number 0910–0338 (also for part 680). 

The provisions of part 1271, subparts C 

and D, are approved under OMB control 

number 0910–0543. 

We note that the information 

collected under the related submission 

types have already been approved and 

are in effect. The collections of 

information regarding formal meetings 

with sponsors and applicants have been 

approved under OMB control number 

0910–0429. The collections of 

information regarding new drug 

approvals (NDA) and abbreviated new 

drug applications (ANDA) have been 

approved under OMB control number 

0910–0001. The collections of 

information regarding pre-ANDAs have 

been approved under OMB control 

number 0910–0797. The collections of 

information regarding pre-submissions 

have been approved under OMB control 

number 0910–0756. The collections of 

information regarding PMAs have been 

approved under OMB control number 

0910–0231. The collections of 

information for premarket notification 

(510(k)) have been approved under 

OMB control number 0910–0120. The 

collections of information for the de 

novo classification process have been 

approved under OMB control number 

0910–0844. The collections of 

information regarding biologics license 

applications have been approved under 

OMB control number 0910–0338. 

VI. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. ‘‘Guidance for Industry and FDA Staff: 

Current Good Manufacturing Practice 

Requirements for Combination 

Products,’’ January 2017. https://

www.fda.gov/RegulatoryInformation/

Guidances/ucm126198.htm. 

2. ‘‘Guidance for Industry: Q1D Bracketing 

and Matrixing Designs for Stability 

Testing of New Drug Substances and 

Products,’’ January 2003. https://www.

fda.gov/downloads/Drugs/Guidances/

ucm073379.pdf. 

3. ‘‘Draft Guidance for Industry: Formal 

Meetings Between the FDA and Sponsors 

or Applicants of PDUFA Products,’’ 

December 2017. https://www.fda.gov/

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

UCM590547.pdf. 

4. ‘‘Draft Guidance for Industry: Formal 

Meetings Between FDA and ANDA 

Applicants of Complex Products Under 

GDUFA,’’ October 2017. https://

www.fda.gov/downloads/drugs/guidance

complianceregulatoryinformation/

guidances/ucm578366.pdf. 

5. ‘‘Guidance for Industry and Food and Drug 

Administration Staff: Requests for 

Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff,’’ September 

2017. https://www.fda.gov/downloads/

medicaldevices/deviceregulationand

guidance/guidancedocuments/

ucm311176.pdf. 

6. ‘‘eCTD Technical Conformance Guide,’’ 

November 2017. https://www.fda.gov/

downloads/Drugs/UCM465411.pdf. 

7. ‘‘Guidance for Industry: Changes to an 

Approved NDA or ANDA,’’ April 2004. 

https://www.fda.gov/downloads/drugs/

guidancecomplianceregulatory

information/guidances/ucm077097.pdf. 

8. ‘‘Draft Guidance for Industry: Chemistry, 

Manufacturing, and Controls Changes to 

an Approved Application: Certain 

Biological Products,’’ December 2017. 

https://www.fda.gov/downloads/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

Guidances/General/UCM590118.pdf. 

9. ‘‘Guidance for Industry and FDA Staff: 30- 

Day Notices, 135-Day Premarket 

Approval (PMA) Supplements and 75- 

Day Humanitarian Device Exemption 

(HDE) Supplements for Manufacturing 

Method or Process Changes,’’ April 2011. 

https://www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/

GuidanceDocuments/UCM080194.pdf. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12634 Filed 6–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0223] 

Humanitarian Device Exemption 

Program; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Humanitarian Device 

Exemption (HDE) Program.’’ This draft 

guidance concerns the HDE program as 

a whole and, among other topics, it 

explains the criteria FDA considers to 

determine if ‘‘probable benefit’’ has 

been demonstrated as part of the 

Agency’s decision-making process 

regarding marketing authorization for a 

humanitarian use device (HUD). The 

draft guidance also incorporates recent 

amendments to the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) that affect 

the HDE program and answers other 

common questions that we receive 

about the program. This draft guidance 

is not final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 13, 2018 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. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27615 

• 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– 

2014–D–0223 for ‘‘Humanitarian Device 

Exemption (HDE) Program.’’ 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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Humanitarian 

Device Exemption (HDE) Program’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002 or the 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 that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6524; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA developed this draft guidance to 

clarify to industry and FDA staff the 

current review practices for the HDE 

program. This draft guidance answers 

common questions about the HDE 

program and responds to a requirement 

in the 21st Century Cures Act (Cures 

Act, Pub. L. 114–255) to define the 

criteria for establishing ‘‘probable 

benefit’’ as that term is used in section 

520(m)(2)(C) of the FD&C Act (21 U.S.C. 

360j(m)(2)(C)). 

This draft guidance incorporates 

recent amendments to the FD&C Act 

that affect the HDE program. 

Specifically, section 3052 of the Cures 

Act modified the eligibility for an HDE 

by increasing the threshold number of 

patients affected by the disease or 

condition that a HUD is designed to 

treat or diagnose to ‘‘not more than 

8,000 individuals in the United States.’’ 

Further, section 3056 the Cures Act 

removed the requirement that 

institutional review committees, i.e., 

institutional review boards (IRBs), that 

supervise the clinical testing of HUDs or 

approve the use of HUDs in clinical care 

be local. 

Additionally, the FDA 

Reauthorization Act of 2017 (Pub. L. 

115–52) amended section 520(m) of the 

FD&C Act to provide that the use of a 

device under an HDE at a facility to treat 

or diagnose patients may be approved 

by an IRB or an appropriate local 

committee. Previously, section 

520(m)(4) of the FD&C Act only allowed 

an IRB to perform this function. FDA is 

providing an interpretation of the term 

‘‘appropriate local committee’’ in this 

draft guidance, and we welcome 

comment on the characteristics that 

should define an appropriate local 

committee for purposes of the HDE 

program. 

This draft guidance supplants the 

draft guidance, ‘‘Humanitarian Device 

Exemption (HDE): Questions and 

Answers—Draft Guidance for HDE 

Holders, IRBs, Clinical Investigators, 

and Food and Drug Administration 

Staff,’’ issued on March 18, 2014. When 

final, this guidance will supersede the 

guidance, ‘‘Guidance for HDE holders, 

IRBs, Clinical Investigators, and Food 

and Drug Administration Staff, HDE 

Regulation: Questions and Answers,’’ 

issued on July 8, 2010, available online 

at: https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/

GuidanceDocuments/UCM110203. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the Humanitarian Device Exemption 

Program. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 


amozie on DSK3GDR082PROD with NOTICES1
27616 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. This 

guidance document is also available at 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Humanitarian Device Exemption 

(HDE) Program’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 17040 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 10 have been approved under OMB 

control number 0910–0191; the 

collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control numbers 0910–0755 

and 0910–0130; the collections of 

information in 21 CFR part 54 have been 

approved under OMB control number 

0910–0396; the collections of 

information in 21 CFR part 803 have 

been approved under OMB control 

number 0910–0437; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 814, 

subparts A through E, have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information regarding 

Information to Accompany HDE 

Applications and Annual Distribution 

Number Reporting Requirements have 

been approved under OMB control 

number 0910–0661; and the collections 

of information in the guidance 

document ‘‘De Novo Classification 

Process (Evaluation of Automatic Class 

III Designation)’’ have been approved 

under OMB control number 0910–0844. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12633 Filed 6–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2032] 

Limited Population Pathway for 

Antibacterial and Antifungal Drugs; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Limited 

Population Pathway for Antibacterial 

and Antifungal Drugs.’’ This guidance 

provides information on the 

implementation of the limited 

population pathway provision of the 

21st Century Cures Act (Cures Act), 

which established the limited 

population pathway for antibacterial 

and antifungal drugs (LPAD pathway). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 13, 2018 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– 

2018–D–2032 for ‘‘Limited Population 

Pathway for Antibacterial and 

Antifungal Drugs; Draft Guidance for 

Industry; Availability.’’ 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 


amozie on DSK3GDR082PROD with NOTICES1