Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69859 

TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1

Product reporting for compounding outsourcing facilities Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of Initial Product Report ................................... 50 1 50 2 100 

Waiver Request from Electronic Submission of Initial Product Report ......................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 101 

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

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Product reporting for compounding outsourcing facilities Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total hours 

Submission of December Product Report ........................... 50 1 50 2 100 

Submission of June Product Report .................................... 50 1 50 2 100 

Waiver Request from Electronic Submission of Product 

Reports ............................................................................. 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 201 

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

III. Comments 

Interested persons can submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments can be viewed at the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27691 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1429] 

Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the FD&C Act; 

Final Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final guidance for 

industry entitled ‘‘Registration of 

Human Drug Compounding Outsourcing 

Facilities Under Section 503B of the 

FD&C Act.’’ The guidance addresses 

new provisions in the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Drug Quality and 

Security Act (DQSA). The guidance is 

intended to assist human drug 

compounders that elect to register as 

outsourcing facilities in registering, reregistering, or de-registering with FDA. 

The guidance provides information on 

how an outsourcing facility should 

submit facility registration information 

electronically in structured product 

labeling (SPL) format using FDA’s 

electronic submission system. This 

guidance reflects the Agency’s current 

thinking on the issues addressed by the 

guidance. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the final guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the final guidance document. 

Submit electronic comments on the 

final guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Soo 

Jin Park, Drug Registration and Listing 

Team, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Registration of Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the FD&C Act.’’ 

This guidance is being issued consistent 

with the new authority conferred to 

FDA in the DQSA (Pub. L. 113–54). In 

that legislation, Congress created a new 

category for certain facilities that 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
69860 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

compound human drugs called 

‘‘outsourcing facilities.’’ Section 

503B(d)(4) of the FD&C Act (21 U.S.C. 

353B(d)(4)) defines an outsourcing 

facility, in part, as a facility that 

complies with all of the requirements of 

section 503B, including registering with 

FDA as an outsourcing facility and 

paying associated fees. If the conditions 

outlined in section 503B(a) of the FD&C 

Act are satisfied, a drug compounded by 

or under the direct supervision of a 

licensed pharmacist in an outsourcing 

facility is exempt from certain sections 

of the FD&C Act, including section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use) and section 

505 (21 U.S.C. 355) (concerning the 

approval of human drug products under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

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

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

manufacturing practice for drugs). This 

guidance is intended to assist 

compounding facilities that wish to 

register as outsourcing facilities to 

register with FDA and discusses the 

process for registering, re-registering, 

and de-registering. 

In the Federal Register of December 4, 

2013 (78 FR 72899), FDA issued a notice 

announcing the availability of the draft 

version of this guidance. That draft 

guidance set forth an interim and 

electronic submission method for 

human drug compounders that elect to 

register as outsourcing facilities. The 

comment period on the draft guidance 

ended on February 3, 2014. FDA 

received nine comments on the draft 

guidance. Some of the received 

comments raised issues that were not 

directly pertinent to the topics 

addressed in this guidance. FDA intends 

to consider those comments as they 

relate to issues being addressed in other 

policy documents being developed by 

the Agency. 

In response to received comments or 

on its own initiative, FDA made the 

following changes as it finalized this 

guidance: (1) We included a phone 

number for a point of contact; (2) we 

deleted reference to an alternative 

interim registration method; (3) we 

added information on how a registered 

outsourcing facility can de-register; (4) 

we clarified what registration 

information will be made public; (5) we 

clarified the standard to be used to grant 

a waiver of the electronic submission 

requirements; and (6) we made 

grammatical and other minor editorial 

changes to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act 

This guidance contains collections of 

information that are subject to review by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520). The 

collections of information have been 

approved under OMB control number 

0910–0777. 

III. Comments 

Interested persons can submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments can be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27693 Filed 11–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–D–0360 and FDA– 

2011–D–0357] 

Framework for Regulatory Oversight of 

Laboratory Developed Tests; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop entitled ‘‘Framework 

for Regulatory Oversight of Laboratory 

Developed Tests (LDTs).’’ The purpose 

of this workshop is to discuss FDA’s 

proposal for a risk-based framework for 

addressing the regulatory oversight of a 

subset of in vitro diagnostic devices 

(IVDs) referred to as laboratory 

developed tests (LDTs), which are 

intended for clinical use and designed, 

manufactured and used within a single 

laboratory, and provide an additional 

opportunity for public comment 

Dates and Times: The 2-day public 

workshop will be held on January 8, 

2015, from 8:30 a.m. to 5:30 p.m. and on 

January 9, 2015 from 8:30 a.m. to 5:30 

p.m. 

Location: The public workshop will 

be held at the Natcher Center at the 

National Institutes of Health Campus, 

9000 Rockville Pike, Bldg. 45, 

Auditorium, Bethesda, MD 20814. For 

parking and security information, please 

refer to http://www.nih.gov/about/

visitor/. 

Contact Person: Allen Webb, Center 

for Devices and Radiological Health, 

Food and Drug Administration, Bldg. 

66, Rm 5675, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 240– 

402–4217, LDTframework@fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this public workshop must register 

online by December 12, 2014, at 4 p.m. 

Early registration is recommended 

because facilities are limited and, 

therefore, FDA may limit the number of 

participants from each organization. If 

time and space permits, onsite 

registration on the day of the public 

workshop will be provided beginning at 

8 a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, (email: Susan.Monahan@

fda.hhs.gov or phone: 301–796–5661) no 

later than December 19, 2014. 

To register for the public workshop, 

please visit FDA’s Medical Devices 

News & Events—Workshops & 

Conferences calendar at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this meeting/public 

workshop from the posted events list.) 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, email, and 

telephone number. If you are unable to 

register online, please contact Susan 

Monahan (see Registration.) Registrants 

will receive confirmation after they have 

been accepted and will be notified if 

they are on a waiting list. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES