45258 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1—Continued 

Respondent description Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT 1

Respondent description Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................... 120 30 3,600 0.20 (12 minutes) ......... 720 

Wholesale Distributors .......................................... 22 1,175 25,850 0.20 (12 minutes) ......... 5,170 

Dispensers ............................................................ 8 2 16 0.20 (12 minutes) ......... 3.2 

Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 

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

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1

Respondent description Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Manufacturers and Repackagers ......................................... 120 1 120 1 120 

Wholesale Distributors ......................................................... 22 1 22 1 22 

Dispensers ........................................................................... 8 1 8 1 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN

ILLEGITIMATE PRODUCT TERMINATION 1

Respondent description Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Manufacturers and Repackagers ......................... 120 30 3,600 0.2 (12 minutes) ........... 720 

Wholesale Distributors .......................................... 22 1,175 25,850 0.2 (12 minutes) ........... 5,170 

Dispensers ............................................................ 8 2 16 0.2 (12 minutes) ........... 3.2 

Total ............................................................... ........................ ........................ ........................ ....................................... 5,893 

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

Cumulatively, the total estimated 

burden is 12,086 annual hours, which 

reflects a significant decrease. We base 

this adjustment on our experience with 

the information collection since its 

establishment and implementation. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19351 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3207] 

Request for Nominations of Voting 

Members on a Public Advisory 

Committee; National Mammography 

Quality Assurance Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the National Mammography 

Quality Assurance Advisory Committee 

in the Center for Devices and 

Radiological Health. Nominations will 

be accepted for upcoming vacancies 

effective with this notice. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Nominations received on or 

before November 5, 2018, will be given 

first consideration for membership on 

the National Mammography Quality 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45259 

Assurance Advisory Committee. 

Nominations received after November 5, 

2018, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Nomination Portal: http://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at http://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT:

Regarding all nomination questions 

for membership: Sara Anderson, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

G616, Silver Spring, MD 20993, 301– 

796–7047, email: Sara.Anderson@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members to fill upcoming vacancies on 

the National Mammography Quality 

Assurance Advisory Committee. 

I. General Description of the Committee 

Duties 

The National Mammography Quality 

Assurance Advisory Committee advises 

the Commissioner of Food and Drugs 

(the Commissioner) or designee on: (1) 

Developing appropriate quality 

standards and regulations for 

mammography facilities; (2) developing 

appropriate standards and regulations 

for bodies accrediting mammography 

facilities under this program; (3) 

developing regulations with respect to 

sanctions; (4) developing procedures for 

monitoring compliance with standards; 

(5) establishing a mechanism to 

investigate consumer complaints; (6) 

reporting new developments concerning 

breast imaging that should be 

considered in the oversight of 

mammography facilities; (7) 

determining whether there exists a 

shortage of mammography facilities in 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; (8) 

determining whether there will exist a 

sufficient number of medical physicists 

after October 1, 1999; and (9) 

determining the costs and benefits of 

compliance with these requirements. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

members, including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

physicians, practitioners, and other 

health professionals, whose clinical 

practice, research specialization, or 

professional expertise includes a 

significant focus on mammography. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified persons for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must specify 

the advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19354 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0277] 

Allergic Rhinitis: Developing Drug 

Products for Treatment; 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 

guidance for industry entitled ‘‘Allergic 

Rhinitis: Developing Drug Products for 

Treatment.’’ The purpose of this 

guidance is to assist sponsors in the 

development of drug products for the 

treatment of allergic rhinitis in children 

and adults. The guidance addresses 

issues of trial design, effectiveness, and 

safety for new products being developed 

for the treatment of seasonal allergic 

rhinitis (SAR) and perennial allergic 

rhinitis (PAR). This guidance 

incorporates the comments received for 

and finalizes the draft guidance of the 

same name issued on February 16, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 6, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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 


daltland on DSKBBV9HB2PROD with NOTICES