Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32881 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

111.75(a)(1)(ii); Determining whether specifications are 

met .................................................................................... 1 1 1 8 8 

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

Since OMB’s last approval of the 

information collection, we have 

received no petitions. We therefore 

retain the currently approved estimated 

burden which assumes no more than 

one petition will be submitted annually. 

We further assume it would take 

respondents 8 hours to prepare the 

factual and legal information necessary 

to support a petition for exemption and 

to prepare the petition, for a total of 8 

burden hours annually. These figures 

are based on our experience with the 

information collection. 

Dated: July 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15088 Filed 7–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0001] 

Scientific Conference: Opioid and 

Nicotine Use, Dependence, and 

Recovery—Influences of Sex and 

Gender; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Office of Women’s Health, Center for 

Drug Evaluation and Research, and 

Center for Tobacco Products are 

announcing the following conference 

entitled ‘‘Scientific Conference: Opioid 

and Nicotine Use, Dependence, and 

Recovery—Influences of Sex and 

Gender.’’ The purpose of the conference 

is to discuss the biological (sex) and 

sociological (gender) influences on 

misuse, abuse, and cessation of opioids 

and tobacco. Researchers, educators, 

and clinicians may benefit from 

attending this multidisciplinary review 

and update on opioid and tobacco. 

DATES: The two-day conference will be 

held on September 27, 2018 (8:30 a.m.– 

4:00 p.m.) and September 28, 2018 (8:30 

a.m.–4:00 p.m.). See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The conference will be held 

at FDA’s White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503–A), Silver Spring, MD 20993. 

Entrance for the conference participants 

(non-FDA employees) is through 

Building 1 where routine security check 

procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Gwendolyn Jones, Food and Drug 

Administration, Bldg. 32, Rm. 2333, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, OWH_OandNConf@

fda.hhs.gov, 301–796–9940. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is responsible for protecting the 

public health by assuring the safety and 

efficacy of FDA-regulated products. This 

conference will provide the Agency 

with further insight into the devastating 

public health crises caused by pervasive 

opioid and tobacco use. Drug overdose 

deaths and opioid-involved deaths 

continue to increase in the United 

States. Many of the drug overdose 

deaths (more than 6 out of 10) involve 

an opioid. Since 1999, the number of 

overdose deaths involving opioids 

(including prescription opioids and 

heroin) quadrupled. Drug overdose 

deaths and opioid-involved deaths 

continue to increase in the United 

States. Of the 63,632 drug overdose 

deaths in 2016, 66.4 percent (42,249) 

involved opioids, with increases across 

age groups, racial/ethnic groups, 

urbanization levels, and multiple states. 

Combustible cigarettes have been 

identified as the dominant cause of 

tobacco-related disease and are 

responsible for more than 20 million 

premature deaths since the first Surgeon 

General’s report in 1964. Together, 

opioid and tobacco use are the leading 

causes of preventable disease and death 

in the United States, and women are 

increasingly affected. Sex and gender 

differences may influence susceptibility 

to substance abuse, which could have 

implications for optimal prevention and 

treatment. Gender influencers also 

impact public health from a familial and 

environmental perspective. Researchers, 

educators, and clinicians must be able 

to recognize and consider both sex and 

gender differences to identify and treat 

women most at risk. 

II. Topics for Discussion at the 

Conference 

The conference will include 

presentations and panel discussions by 

experts in the field of opioid and 

tobacco research, professional 

education, and clinical care on the 

biological (sex) and sociological 

(gender) influences on misuse, abuse, 

and cessation of opioids and tobacco. 

Each panel discussion will have a Q&A 

session to respond to questions from inperson attendees. 

III. Participating in the Conference 

Registration: To register for the 

Scientific Conference: Opioid and 

Nicotine Use, Dependence, and 

Recovery—Influences of Sex and 

Gender, please visit the following 

website: https://www.eventbrite.com/e/ 

scientific-conference-opioid-andnicotine-use-dependence-and-recoveryinfluences-of-sex-and-gender-tickets47087275308. 

Registration is free and in-person 

seating is limited. The conference will 

also be available for viewing via 

webcast. Persons interested in attending 

or viewing this conference must register 

online by September 24, 2018, 5:00 p.m. 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. If you need special 

accommodations due to a disability, 

please email Gwendolyn Jones at OWH_

OandNConf@fda.hhs.gov (See FOR

FURTHER INFORMATION CONTACT) no later 

than September 24, 2018. 

Streaming Webcast of the public 

meeting: This public meeting will also 

be webcast and can only be viewed if 

registered. To register, please go to 


sradovich on DSK3GMQ082PROD with NOTICES
32882 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

https://www.eventbrite.com/e/scientificconference-opioid-and-nicotine-usedependence-and-recovery-influences-ofsex-and-gender-tickets-47087275308. 

Registrants will receive confirmation 

and information about accessing the 

webcast when they have been accepted. 

FDA has verified the website addresses 

in this document, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

Dated: July 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15096 Filed 7–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–4318] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Compounding and 

Repackaging of Radiopharmaceuticals 

by State-Licensed Nuclear Pharmacies, 

Federal Facilities, and Certain Other 

Entities 

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 August 15, 

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–NEW and 

title ‘‘Guidance for Industry on 

Compounding and Repackaging of 

Radiopharmaceuticals by State-Licensed 

Nuclear Pharmacies, Federal Facilities, 

and Certain Other Entities.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Guidance for Industry on Compounding 

and Repackaging of 

Radiopharmaceuticals by StateLicensed Nuclear Pharmacies, Federal 

Facilities, and Certain Other Entities 

OMB Control Number—NEW 

This information collection supports 

the Agency guidance document entitled 

‘‘Guidance for Industry on 

Compounding and Repackaging of 

Radiopharmaceuticals by State-Licensed 

Nuclear Pharmacies, Federal Facilities, 

and Certain Other Entities.’’ 

Under current law, 

radiopharmaceuticals that are 

compounded by entities that are not 

registered with FDA as outsourcing 

facilities, and radiopharmaceuticals that 

are repackaged, are subject to all 

applicable provisions of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) related to drug production. Because 

Congress explicitly excluded 

radiopharmaceuticals from section 503A 

of the FD&C Act (21 U.S.C. 353a) (see 

section 503A(d)(2)), compounded 

radiopharmaceuticals are not eligible for 

the exemptions under section 503A 

from section 505 of the FD&C Act (21 

U.S.C. 355) (concerning new drug 

approval requirements), section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) (concerning labeling with 

adequate directions for use), and section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice requirements). 

In addition, the FD&C Act does not 

provide an exemption for repackaged 

radiopharmaceuticals. 

FDA developed this guidance 

document to describe the conditions 

under which the Agency generally does 

not intend to take action for violations 

of sections 505, 502(f)(1), and 

501(a)(2)(B) of the FD&C Act when a 

State-licensed nuclear pharmacy, 

Federal facility, or other facility that is 

not an outsourcing facility and that 

holds a radioactive materials license for 

medical use issued by the Nuclear 

Regulatory Commission or by an 

Agreement State compounds or 

repackages radiopharmaceuticals for 

human use. 

One of the guidance document’s 

conditions is that the compounded 

radiopharmaceutical is not essentially a 

copy of an approved 

radiopharmaceutical. If a compounder 

intends to rely on a determination from 

a prescriber that there is a change 

between the compounded 

radiopharmaceutical and the 

comparable approved 

radiopharmaceutical that produces a 

clinical difference for an identified 

individual patient, either the 

prescribing practitioner or the 

compounder documents the 

determination on the prescription or 

order in writing. This documentation 

reflects a conversation with the 

prescribing practitioner, and the 

compounder maintains records of the 

prescription or order documenting this 

determination. 

In the Federal Register of December 

29, 2016 (81 FR 96011), FDA published 

a notice of availability for the draft 

guidance, including a 60-day notice 

soliciting public comment on the 

information collection 

recommendations. Several comments 

were received and are discussed below; 

however, none of the comments 

suggested we revise the burden estimate 

from our 60-day notice. 

(Comment 1) One commenter said 

documentation of a minor deviation 

from an approved radiopharmaceutical 

should remain at the facility that 

performed the minor deviation. 

(Response 1) The documentation 

condition (i.e., documentation of a 

prescriber’s determination that there is 

a change that produces a clinical 

difference between the compounded 

radiopharmaceutical and the 

comparable FDA-approved 

radiopharmaceutical for an identified 

individual patient) does not apply to 

compounding that consists only of 

minor deviations as defined in the 

guidance document (i.e., a change from 

the approved labeling in radioactivity, 

volume, or the step-by-step procedures 

made when compounding the 

radiopharmaceutical from an FDAapproved drug product in a patientready dose). The documentation 

condition applies to compounding a 

radiopharmaceutical that involves 

manipulation other than minor 

deviations. 

(Comment 2) One commenter 

supports the requirement for notating 

clinical differences, particularly for 

documenting both the change to the 

radiopharmaceutical and the reason that 

the change is important for the patient. 

(Response 2) FDA concurs with this 

commenter’s views about the 

importance of the documentation. 


sradovich on DSK3GMQ082PROD with NOTICES