228 Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 

Dated: December 28, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28474 Filed 1–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3077] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Obtaining 

Information To Understand Challenges 

and Opportunities Encountered by 

Compounding Outsourcing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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: Submit written comments 

(including recommendations) on the 

collection of information by February 3, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0883. 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. 

Obtaining Information To Understand 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities 

OMB Control Number 0910–0883— 

Extension 

This information collection supports 

FDA research in obtaining a range of 

information pertaining to human 

prescription drug compounding by 

outsourcing facilities. Generally, drug 

compounding is the practice of 

combining, mixing, or altering 

ingredients of a drug to create a 

medication tailored to an individual 

patient’s needs. Although compounded 

drugs can serve an important medical 

need for certain patients when an 

approved drug is not medically 

appropriate, compounded drugs also 

present a risk to patients. Compounded 

drugs are not FDA-approved; therefore, 

they do not undergo FDA premarket 

review for safety, effectiveness, and 

quality. 

Section 503A of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 353a) describes the conditions 

that must be satisfied for compounded 

human prescription drug products to be 

exempt from certain sections of the 

FD&C Act: (1) Section 501(a)(2)(B) (21 

U.S.C. 351(a)(2)(B)) (current good 

manufacturing practice (CGMP) 

requirements), (2) section 502(f)(1) (21 

U.S.C. 352(f)(1)) (labeling of drugs with 

adequate directions for use), and (3) 

section 505 (21 U.S.C. 355) (approval of 

drugs under new drug applications or 

abbreviated new drug applications). 

The Drug Quality and Security Act of 

2013 (Pub. L. 113–54) created 

‘‘outsourcing facilities’’—a new industry 

sector of drug compounders held to 

higher quality standards to protect 

patient health. Section 503B of the 

FD&C Act (21 U.S.C. 353b) describes the 

conditions that outsourcing facilities 

must satisfy for drug products 

compounded in an outsourcing facility 

by or under the direct supervision of a 

licensed pharmacist to be exempt from 

certain sections of the FD&C Act. 

Outsourcing facilities are intended to 

offer a more reliable supply of 

compounded drugs that hospitals, 

clinics, and other providers need. 

FDA continues to find concerning 

quality and safety problems during 

inspections of outsourcing facilities. 

FDA has implemented and will 

continue to implement programs to 

support compounding quality and 

compliance. One initiative is FDA’s 

Compounding Quality Center of 

Excellence (Center of Excellence), 

https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence, which was 

developed to focus on improving the 

quality of compounded human 

prescription drugs to promote patient 

safety. One of our top priorities is to 

help ensure that compounded drugs are 

safe by focusing on quality. FDA, State 

regulators, pharmacy associations, and 

compounders, including outsourcing 

facilities, share the responsibility for 

patient safety. 

The Center of Excellence engages and 

collaborates with compounders, 

including outsourcing facilities, and 

other stakeholders to improve the 

overall quality of compounded drugs. 

Furthermore, the Center of Excellence 

promotes collaboration to help 

compounders implement robust quality 

management systems that are better for 

business and the safety of patients. 

To help strengthen the outsourcing 

facility industry’s ability to provide 

quality compounded drugs to patients 

who need them, the Center of 

Excellence offers training sessions and 

opportunities to develop manufacturing 

quality and other policies for 

outsourcing facilities, including CGMPs. 

The Center of Excellence offers 

several training sessions (available at 

https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence-trainingprograms). Self-guided training sessions 

teach the following topics: (1) 

Environmental monitoring, (2) sterile 

drug compounding, (3) cleanroom 

performance tests, and (4) conducting 

investigations and formulating 

corrective and preventive actions. 

Instructor-led sessions teach the 

regulatory framework for these topics: 

(1) Human drug compounding, (2) 

airflow practices, (3) insanitary 

conditions and sterility, (4) stability and 

beyond use dates, (5) requirements for 

outsourcing facility guides, and (6) 

conducting investigations and 

formulating corrective and preventive 

actions. Management and staff from 

outsourcing facilities have attended the 

training sessions. Feedback on the 

training sessions has been positive, and 

interest in the sessions continues to 

grow. 

In addition, the Center of Excellence 

is conducting in-depth research to better 

understand outsourcing facilities’ 

challenges and opportunities in 

different areas to help guide decisions 

regarding future training and other 

engagement. Outsourcing facilities 

encounter the following challenges and 

opportunities: (1) Operational barriers 

and opportunities related to the 

outsourcing facility market and business 

viability, (2) knowledge and operational 

barriers and opportunities related to 


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 229 

compliance with Federal policies and 

good quality drug production, and (3) 

barriers and opportunities related to 

outsourcing facility interactions with 

FDA. 

FDA used previous research results 

under this information collection to 

develop an understanding of the 

outsourcing facility sector, the sector’s 

challenges, and opportunities for 

advancement. The information collected 

was an essential tool to help FDA 

identify knowledge and information 

gaps, operational barriers, and views on 

interactions with FDA. FDA has 

presented this information in public 

settings, such as stakeholder meetings. 

Continuing this collection will enable 

FDA to deepen our understanding of the 

outsourcing facility sector and increase 

our efficacy in developing a Center of 

Excellence that is responsive to 

outsourcing facilities’ needs. The 

research results will inform FDA’s 

future activities for the Center of 

Excellence in the areas of 

communication, education, training, 

and other engagement with outsourcing 

facilities to address challenges and 

support advancement. 

Researchers engage with pharmacists, 

staff, management from outsourcing 

facilities, similar compounding 

businesses, and related stakeholders and 

may use surveys, interviews, and focus 

groups to obtain information about 

outsourcing facilities’ challenges and 

opportunities. Within this context, we 

may pose the following questions or 

similar, related questions: 

1. What financial and operational 

considerations inform outsourcing 

facility operational and business model 

decisions? 

2. What factors impact developing a 

sustainable outsourcing facility 

business? 

3. What financial and operational 

considerations inform outsourcing 

facility product decisions? 

4. Do outsourcing facilities 

understand the Federal laws and 

policies that apply to them? What, if 

any, knowledge gaps do we need to 

address? 

5. What are outsourcing facilities’ 

challenges when implementing Federal 

CGMP requirements? 

6. How do outsourcing facilities 

implement quality practices at their 

facilities? 

7. How do outsourcing facilities 

develop CGMP and quality expertise? 

How do they obtain this knowledge, and 

what training do they need? 

8. What are the economic 

consequences of CGMP noncompliance 

and product failures for outsourcing 

facilities? 

9. What are outsourcing facility 

management and staff views on current 

interactions with FDA? How do they 

want the interactions to change? 

10. What are outsourcing facilities’ 

understanding of how to engage with 

FDA during and following an 

inspection? 

In the Federal Register of October 1, 

2021 (86 FR 54450), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment from an industry association 

relating to the quality of questions 

previously posed to industry 

stakeholders concerning outsourcing 

facilities. Specifically, the commenter 

stated that the proposed questions 

included in the 60-day notice were 

insufficient to fully acquire information 

relating to the challenges and 

opportunities outsourcing facilities face. 

Accordingly, the commenter provided a 

number of additional questions for FDA 

to use, which the commenter believes 

will better solicit relevant information. 

FDA has considered the commenter’s 

additional questions and will take them 

under advisement for possible inclusion 

in future studies. However, at this time 

FDA will not include the commenter’s 

questions in this particular study 

because we believe the proposed 

questions listed in the 60-day notice 

will sufficiently solicit the specific 

information we are currently seeking. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Surveys, focus groups, and interviews ................................ 300 2 600 1 600 

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

Our original request for the 

information collection was approved 

January 21, 2020; however, the 

subsequent public health emergency 

inhibited our ability to administer the 

requested survey. We have therefore 

made no adjustments to our current 

burden estimate. 

Dated: December 28, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28465 Filed 1–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Recourses and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 86 FR 48737–48743 

dated August 31, 2021). 

This reorganization updates the 

functions of the HIV/AIDS Bureau’s 

Division Policy and Data (RVA). 

Chapter RVA—Division of Policy and 

Data 

Section RVA.20 Function 

Delete the functional statement for the 

Division of Policy and Data (RVA) in its 

entirety and replace with the following: 

Division of Policy and Data (RVA) 

The Division of Policy and Data 

serves as the Bureau’s focal point for 

program data collection and analysis, 

development of policy guidance, 

advancement of implementation 

science, and analyses of data for reports 

for dissemination, coordination of 

program and clinical performance 

activities, and technical assistance and 

training internally and externally. The 

division directs and manages the 

portfolio of recipients and programs 

funded under Special Projects of 


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