41626 Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0838] 

Procedures for Meetings of the Medical 

Devices Advisory Committee; 

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 

guidance entitled ‘‘Procedures for 

Meetings of the Medical Devices 

Advisory Committee.’’ The Center for 

Devices and Radiological Health (CDRH) 

is issuing this guidance to provide 

additional information regarding the 

processes for meetings of the Medical 

Devices Advisory Committee panels 

other than the Medical Devices Dispute 

Resolution Panel (DRP). This guidance 

describes the general circumstances in 

which CDRH consults with a panel, the 

process for exchange of information 

among CDRH, the members of the panel, 

industry, and the public, and the 

conduct of panel meetings. This 

guidance supplements existing FDA 

Agency-wide guidance on the conduct 

of Advisory Committee meetings. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: You may submit comments 

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– 

2015–D–0838 for ‘‘Procedures for 

Meetings of the Medical Devices 

Advisory Committee; Guidance for 

Industry and Food and Drug 

Administration Staff; 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 Office 

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. 

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 guidance 

document entitled ‘‘Procedures for 

Meetings of the Medical Devices 

Advisory Committee’’ 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. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1609, Silver Spring, 

MD 20993–0002, 301–796–6313. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is issuing this guidance to 

provide additional information 

regarding the processes for meetings of 

the Medical Devices Advisory 

Committee panels other than DRP. The 

term ‘‘panel,’’ as used in this guidance, 

refers to the panels established under 

the Medical Devices Advisory 

Committee charter excluding DRP. This 

guidance describes the general 

circumstances in which CDRH consults 

with a panel of the Medical Devices 

Advisory Committee, the process for 

exchange of information among CDRH, 

the members of the panel, industry, and 

the public, and the conduct of panel 

meetings. The Medical Devices 

Advisory Committee includes 17 panels 

other than DRP (Ref. 1). The panels, 

according to their specialty area and 

authorization, advise the Commissioner 

of Food and Drugs in discharging 

responsibilities as they relate to assuring 

the safety and effectiveness of medical 

devices, and as required, any other 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 41627 

product for which FDA has regulatory 

responsibility. 

In the Federal Register of April 1, 

2015 (80 FR 17439), FDA announced the 

availability of the draft guidance. 

Interested persons were invited to 

comment by June 1, 2015. FDA revised 

the guidance as appropriate in response 

to the comments. This guidance is 

intended to provide information for 

industry and for CDRH staff on the 

processes associated with a panel 

meeting held for any of the reasons 

identified in the guidance. This 

guidance replaces the ‘‘Guidance on 

Amended Procedures for Advisory 

Panel Meetings’’ (Ref. 2) and the 

guidance document entitled ‘‘Panel 

Review of Premarket Approval 

Applications #P91–2 blue book memo’’ 

(Ref. 3). This guidance supplements 

existing FDA Agency-wide guidance on 

the conduct of Advisory Committee 

meetings. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the panel meeting 

process for medical devices. 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 guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Procedures for Meetings of the 

Medical Devices Advisory Committee’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 413 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

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). The collections of information in 

21 CFR part 807, subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 860 have 

been approved under OMB control 

number 0910–0138; the collections of 

information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231; and the collections 

of information in 21 CFR part 814, 

subpart H have been approved under 

OMB control number 0910–0332. 

V. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES), and may be seen 

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 Web site addresses, as of the 

date this document publishes in the 

Federal Register, but Web sites are 

subject to change over time. 

1. CDRH’s Medical Devices Advisory 

Committee, available at https:// 

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Medical

Devices/MedicalDevicesAdvisoryCommittee/ 

default.htm. 

2. ‘‘Guidance for Industry and FDA Staff: 

Guidance on Amended Procedures for 

Advisory Panel Meetings,’’ July 2000, 

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

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/ 

ucm073726.pdf. 

3. ‘‘Panel Review of Premarket Approval 

Applications #P91–2 (blue book memo),’’ 

May 1991, available at https://www.fda.gov/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/ 

ucm081363.htm. 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18549 Filed 8–31–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the program in 

general, contact Lisa L. Reyes, Acting 

Clerk, United States Court of Federal 

Claims, 717 Madison Place NW., 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, MD 20857; (301) 443–6593, 

or visit our Web site at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the U.S. Court of Federal Claims and to 

serve a copy of the petition on the 

Secretary of HHS, who is named as the 

respondent in each proceeding. The 

Secretary has delegated this 

responsibility under the program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 


sradovich on DSK3GMQ082PROD with NOTICES