32880 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15092 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–1011] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Petition To 

Request an Exemption From 100 

Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

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 0910–0608. 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. 

Petition To Request an Exemption From 

100 Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements—21 CFR 111.75(a)(1)(ii) 

OMB Control Number 0910–0608— 

Extension 

This information collection supports 

Agency regulations. The Dietary 

Supplement Health and Education Act 

(Pub. L. 103–417) added section 402(g) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 342(g)), 

which provides, in part, that the 

Secretary of Health and Human Services 

may, by regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g)(1) of the 

FD&C Act states that a dietary 

supplement is adulterated if it has been 

prepared, packed, or held under the 

types of conditions that do not meet 

current good manufacturing practice 

regulations. Section 701(a) of the FD&C 

Act (21 U.S.C. 371(a)) gives us the 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

Part 111 (21 CFR part 111) establishes 

the minimum Current Good 

Manufacturing Practice (CGMP) 

necessary for activities related to 

manufacturing, packaging, labeling, or 

holding dietary supplements to ensure 

the quality of the dietary supplement. 

Section 111.75(a)(1) of our regulations 

(21 CFR 111.75(a)(1)) establishes a 

procedure for a petition to request an 

exemption from 100 percent identity 

testing of dietary ingredients. Under 

§ 111.75(a)(1)(ii), manufacturers may 

request an exemption from the 

requirements set forth in 

§ 111.75(a)(1)(i) when the dietary 

ingredient is obtained from one or more 

suppliers identified in the petition. The 

regulation clarifies that we are willing to 

consider, on a case-by-case basis, a 

manufacturer’s conclusion, supported 

by appropriate data and information in 

the petition submission, that it has 

developed a system that it would 

implement as a sound, consistent means 

of establishing, with no material 

diminution of assurance compared to 

the assurance provided by 100 percent 

identity testing, the identity of the 

dietary ingredient before use. 

Section 111.75(a)(1) reflects our 

determination that manufacturers that 

test or examine 100 percent of the 

incoming dietary ingredients for 

identity can be assured of the identity 

of the ingredient. However, we 

recognize that it may be possible for a 

manufacturer to demonstrate, through 

various methods and processes in use 

over time for its particular operation, 

that a system of less than 100 percent 

identity testing would result in no 

material diminution of assurance of the 

identity of the dietary ingredient as 

compared to the assurance provided by 

100 percent identity testing. To provide 

an opportunity for a manufacturer to 

make such a showing and reduce the 

frequency of identity testing of 

components that are dietary ingredients 

from 100 percent to some lower 

frequency, we added to § 111.75(a)(1), 

an exemption from the requirement of 

100 percent identity testing when a 

manufacturer petitions the Agency for 

such an exemption to 100 percent 

identity testing under § 10.30 (21 CFR 

10.30) and the Agency grants such 

exemption. Such a procedure would be 

consistent with our stated goal, as 

described in the CGMP final rule, of 

providing flexibility in the CGMP 

requirements. Section 111.75(a)(1)(ii) 

sets forth the information a 

manufacturer is required to submit in 

such a petition. The regulation also 

contains a requirement to ensure that 

the manufacturer keeps our response to 

a petition submitted under 

§ 111.75(a)(1)(ii) as a record under 

§ 111.95 (21 CFR 111.95). The collection 

of information in § 111.95 has been 

approved under OMB control number 

0910–0606. 

In the Federal Register of April 9, 

2018 (83 FR 15159), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

suggesting that ‘‘microbial cultures and 

probiotics should not be required to go 

through such a process to ensure 

exemption from the Agency’s 100 

percent identity testing requirement,’’ 

but did not suggest a revision to the 

estimated burden. We appreciate this 

comment, however, we believe that the 

current requirements impose minimal 

information collection while 

simultaneously ensuring the safety of 

dietary supplements. 

We estimate the burden of the 

information collection as follows: 


sradovich on DSK3GMQ082PROD with NOTICES
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