1262 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6827] 

Advisory Committee; Vaccines and 

Related Biological Products Advisory 

Committee, Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Vaccines and Related 

Biological Products Advisory 

Committee by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

Vaccines and Related Biological 

Products Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until December 31, 2019. 

DATES: Authority for the Vaccines and 

Related Biological Products Advisory 

Committee will expire on December 31, 

2019, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Division of 

Scientific Advisors and Consultants, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6338, Silver Spring, MD 20993–0002, 

240–402–5771, serina.hunter-thomas@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Vaccines and Related Biological 

Products Advisory Committee (the 

Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective vaccines and related biological 

products for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and, as required, any 

other products for which FDA has 

regulatory responsibility. The 

Committee also considers the quality 

and relevance of FDA’s research 

program, which provides scientific 

support for the regulation of these 

products and makes appropriate 

recommendations to the Commissioner. 

The Committee shall consist of a core 

of 15 voting members, including the 

Chairperson (the Chair). Members and 

the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of immunology, molecular biology, 

rDNA, virology, bacteriology, 

epidemiology or biostatistics, vaccine 

policy, vaccine safety science, federal 

immunization activities, vaccine 

development including translational 

and clinical evaluation programs, 

allergy, preventive medicine, infectious 

diseases, pediatrics, microbiology, and 

biochemistry. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Ex 

Officio voting members one each from 

the Department of Health and Human 

Services, the Centers for Disease Control 

and Prevention, and the National 

Institutes of Health may be included. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one non-voting member who is 

identified with industry interests. There 

may also be an alternate industry 

representative. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) Expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members) or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, a non-voting representative of 

consumer interests and a non-voting 

representative of industry interests will 

be included in addition to the voting 

members. 

Further information regarding the 

most recent charter and other 

information can be found at: https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Blood

VaccinesandOtherBiologics/ 

VaccinesandRelatedBiologicalProducts

AdvisoryCommittee/ucm129571.htm or 

by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. This document is issued under 

the Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00239 Filed 1–9–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0312] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Extralabel Drug Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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. 

DATES: Fax written comments on the 

collection of information by February 9, 

2018. 

ADDRESSES: 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, 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 1263 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0325. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 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. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Extralabel Drug Use in Animals—21 

CFR Part 530 

OMB Control Number 0910–0325— 

Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 (Pub. L. 103– 

396) allows a veterinarian to prescribe 

the extralabel use of approved new 

animal drugs. Also, it permits FDA, if it 

finds that there is a reasonable 

probability that the extralabel use of an 

animal drug may present a risk to the 

public health, to establish a safe level 

for a residue from the extralabel use of 

the drug, and to require the 

development of an analytical method for 

the detection of residues above that 

established safe level (21 CFR 

530.22(b)). Although, to date, we have 

not established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal and/or State Agencies, 

academia, or individuals. 

In the Federal Register of June 26, 

2017 (82 FR 28858), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

530.22(b), Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320 

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

The burden estimate has not changed, 

and remains the same. 

Dated: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00237 Filed 1–9–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2017–N–4951] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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. 

DATES: Fax written comments on the 

collection of information by February 9, 

2018. 

ADDRESSES: 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 

comments should be identified with the 

OMB control number 0910–0332. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Humanitarian Use 

Devices—21 CFR Part 814 

OMB Control Number 0910–0332— 

Extension 

This collection of information 

implements the humanitarian use 

devices (HUDs) provision of section 

520(m) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(m)) and part 814, subpart H (21 

CFR part 814, subpart H). Under section 

520(m) of the FD&C Act, FDA is 

authorized to exempt an HUD from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act (21 U.S.C. 

360d and 360e) provided that the 

device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 


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