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, 75328-75330 [2020-26066]

Download as PDF 75328 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices ESTIMATED OPPORTUNITY BURDEN FOR RESPONDENTS Annual number of respondents Instrument Healthcare providers: Serious Medical Procedure Request (SMR) Form ....... Annual number of responses per respondent 195 Average burden hours per response 1 .22 Total burden hours Annual burden hours 128.7 42.9 Estimated Total Annual Burden Hours: 42.9. Annual number of respondents Instrument ORR Grantee Staff: Serious Medical Procedure Request (SMR) Form ....... Annual number of responses per respondent 195 Average burden hours per response 1 .08 Total burden hours Annual burden hours 46.8 15.6 Estimated Total Annual Burden Hours: 15.6. ESTIMATED RECORDKEEPING BURDEN FOR RESPONDENTS Annual number of respondents Instrument ORR Grantee Staff: Serious Medical Procedure Request (SMR) Form ....... Estimated Total Annual Burden Hours: 15.6. Authority: 6 U.S.C. Section 279: Exhibit 1, part A.2 of the Flores Settlement Agreement (Jenny Lisette Flores, et al., v. Janet Reno, Attorney General of the United States, et al., Case No. CV 85–4544–RJK [C.D. Cal. 1996]). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–26121 Filed 11–24–20; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3077] jbell on DSKJLSW7X2PROD with NOTICES 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. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 16:27 Nov 24, 2020 Jkt 253001 Annual number of responses per respondent 195 1 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 December 28, 2020. 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. 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. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Average burden hours per response .08 Total burden hours Annual burden hours 46.8 15.6 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 Agency-sponsored research. Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health. The Drug Quality and Security Act of 2013 (Pub. L. 113–54) created ‘‘outsourcing facilities’’—a new industry sector of drug compounders held to E:\FR\FM\25NON1.SGM 25NON1 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Seven years since its creation, this domestic industry is still relatively small and is experiencing growth and market challenges. In addition, FDA continues to find concerning quality and safety problems during inspections. To help this industry meet its intended function, FDA intends to engage in several initiatives to address challenges and support compliance and advancement. One initiative includes conducting in-depth research to understand better the challenges and opportunities encountered by the outsourcing facility sector in a number of different areas. These include: Operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities related to compliance with Federal policies and good quality drug production; and barriers and opportunities related to outsourcing facility interactions with FDA. This is an extension of research that began last year. We have learned about barriers and opportunities encountered by outsourcing facilities in several areas. These include: Operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities related to compliance with Federal policies and good quality drug production; and barriers and opportunities related to outsourcing facility interactions with FDA. We need to extend this information collection for two reasons: (1) Based on what we learned, we will want to ask some follow up questions in these areas; (2) We received a low response rate and need to reach the rest of the outsourcing facility industry. We only managed to obtain completed surveys from approximately one third of respondents. Only 45 percent of outsourcing facilities provided any response to the survey. Therefore, over half of outsourcing facilities did not respond to our survey, and we were unable to obtain their viewpoints. The results of this research will be used by FDA to develop a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. The information will be essential to help identify knowledge and information gaps, operational barriers, and views on interactions with FDA. The research results will inform FDA’s future approaches to communication, education, training, and other engagement with outsourcing facilities to address challenges and support advancement. Researchers will engage pharmacists, staff, and management from outsourcing facilities and similar compounding businesses. Researchers may use surveys, interviews, and focus groups to obtain information concerning challenges and opportunities encountered by outsourcing facilities. Within this context, the following questions or similar, related questions may be posed: 1. What financial and operational considerations inform outsourcing facility operational and business model decisions? 2. What factors impact the development of a sustainable outsourcing facility business? 3. What financial and operational considerations inform outsourcing facility product decisions? 4. Do outsourcing facilities understand the Federal legislative and regulatory policies that apply to them? 75329 What, if any, knowledge gaps need to be addressed? 5. What challenges do outsourcing facilities face when implementing Federal current good manufacturing practice (CGMP) requirements? 6. How do outsourcing facilities implement quality practices at their facilities? 7. How is CGMP and quality expertise developed by outsourcing facilities? How do they obtain this knowledge, and what training do they need? 8. What are the economic consequences of CGMP noncompliance/ 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 June 18, 2020 (85 FR 36857), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received four comments. Although four comments were received, three were not responsive to the four collection of information topics solicited and, therefore, will not be discussed in this document. The other comment included a number of suggested questions to expand upon the questions posed in the 60-day notice and, therefore, can be considered ways to enhance the quality, utility, and clarity of the information to be collected. While the questions will not be included verbatim in our survey instrument, FDA will give the questions due consideration as the Agency proceeds with this study. 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 jbell on DSKJLSW7X2PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 16:27 Nov 24, 2020 Jkt 253001 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 E:\FR\FM\25NON1.SGM 25NON1 75330 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: November 16, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–26066 Filed 11–24–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1677] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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: Submit written comments (including recommendations) on the collection of information by December 28, 2020. 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 0910–0623. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:27 Nov 24, 2020 Jkt 253001 collection of information to OMB for review and clearance. Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle—21 CFR 189.5 and 700.27 OMB Control Number 0910–0623— Extension FDA’s regulations in §§ 189.5 and 700.27 (21 CFR 189.5 and 700.27) set forth bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA-regulated human food and cosmetics. The regulations designate certain materials from cattle as ‘‘prohibited cattle materials,’’ including specified risk materials (SRMs), the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) beef. Sections 189.5(c) and 700.27(c) set forth the requirements for recordkeeping and records access for FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. We issued these recordkeeping regulations under the adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C Act, we are authorized to issue regulations for the FD&C Act’s efficient enforcement. With regard to records concerning imported human food and cosmetics, we relied on our authority under sections 701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)). Section 801(a) of the FD&C Act provides requirements with regard to imported human food and cosmetics and provides for refusal of admission of human food and cosmetics that appear to be adulterated into the United States. Section 701(b) of the FD&C Act authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. These requirements are necessary because once materials are separated from an animal it may not be possible, without records, to know the following: (1) Whether cattle material may contain SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from animals 30 months and older and tonsils and distal ileum of the small intestine from all animals of all ages); (2) whether the source animal for cattle material was inspected and passed; (3) whether the source animal for cattle material was nonambulatory disabled, or MS beef; and (4) whether tallow in human food or cosmetics contain less than 0.15 percent insoluble impurities. FDA’s regulations in §§ 189.5(c) and 700.27(c) require manufacturers and processors of human food and cosmetics manufactured from, processed with, or otherwise containing material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetics are not manufactured from, processed with, or otherwise contain prohibited cattle materials. These records must be retained for 2 years at the manufacturing or processing establishment or at a reasonably accessible location. Maintenance of electronic records is acceptable, and electronic records are considered to be reasonably accessible if they are accessible from an onsite location. Records required by these sections and existing records relevant to compliance with these sections must be available to FDA for inspection and copying. Existing records may be used if they contain all of the required information and are retained for the required time period. Because we do not easily have access to records maintained at foreign establishments, FDA regulations in §§ 189.5(c)(6) and 700.27(c)(6), respectively, require that when filing for entry with U.S. Customs and Border Protection, the importer of record of human food or cosmetics manufactured from, processed with, or otherwise containing, cattle material must affirm that the human food or cosmetics were manufactured from, processed with, or otherwise contains, cattle material and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of §§ 189.5 or 700.27. In addition, if human food or cosmetics were manufactured from, processed with, or otherwise contains cattle material, the importer of record must provide within 5 business days records sufficient to demonstrate that the human food or cosmetics were not manufactured from, processed with, or otherwise contains prohibited cattle material, if requested. Under FDA’s regulations, we may designate a country from which cattle materials inspected and passed for E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75328-75330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26066]


-----------------------------------------------------------------------

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) 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 December 28, 2020.

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, 
[email protected].

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 Agency-sponsored research. 
Drug compounding is generally the practice of combining, mixing, or 
altering ingredients of a drug to create a medication tailored to the 
needs of an individual patient. Although compounded drugs can serve an 
important medical need for certain patients when an approved drug is 
not medically appropriate, they also present a risk to patients. 
Compounded drugs are not FDA-approved. Therefore, they do not undergo 
premarket review by FDA for safety, effectiveness, and quality. Since 
compounded drugs are subject to a lower regulatory standard than 
approved drugs, Federal law places conditions on compounding that are 
designed to protect the public health.
    The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created 
``outsourcing facilities''--a new industry sector of drug compounders 
held to

[[Page 75329]]

higher quality standards to protect patient health. Outsourcing 
facilities are intended to offer a more reliable supply of compounded 
drugs needed by hospitals, clinics, and other providers. Seven years 
since its creation, this domestic industry is still relatively small 
and is experiencing growth and market challenges. In addition, FDA 
continues to find concerning quality and safety problems during 
inspections.
    To help this industry meet its intended function, FDA intends to 
engage in several initiatives to address challenges and support 
compliance and advancement. One initiative includes conducting in-depth 
research to understand better the challenges and opportunities 
encountered by the outsourcing facility sector in a number of different 
areas. These include: Operational barriers and opportunities related to 
the outsourcing facility market and business viability; knowledge and 
operational barriers and opportunities related to compliance with 
Federal policies and good quality drug production; and barriers and 
opportunities related to outsourcing facility interactions with FDA.
    This is an extension of research that began last year. We have 
learned about barriers and opportunities encountered by outsourcing 
facilities in several areas. These include: Operational barriers and 
opportunities related to the outsourcing facility market and business 
viability; knowledge and operational barriers and opportunities related 
to compliance with Federal policies and good quality drug production; 
and barriers and opportunities related to outsourcing facility 
interactions with FDA. We need to extend this information collection 
for two reasons: (1) Based on what we learned, we will want to ask some 
follow up questions in these areas; (2) We received a low response rate 
and need to reach the rest of the outsourcing facility industry. We 
only managed to obtain completed surveys from approximately one third 
of respondents. Only 45 percent of outsourcing facilities provided any 
response to the survey. Therefore, over half of outsourcing facilities 
did not respond to our survey, and we were unable to obtain their 
viewpoints. The results of this research will be used by FDA to develop 
a comprehensive understanding of the outsourcing facility sector, its 
challenges, and opportunities for advancement. The information will be 
essential to help identify knowledge and information gaps, operational 
barriers, and views on interactions with FDA. The research results will 
inform FDA's future approaches to communication, education, training, 
and other engagement with outsourcing facilities to address challenges 
and support advancement.
    Researchers will engage pharmacists, staff, and management from 
outsourcing facilities and similar compounding businesses. Researchers 
may use surveys, interviews, and focus groups to obtain information 
concerning challenges and opportunities encountered by outsourcing 
facilities. Within this context, the following questions or similar, 
related questions may be posed:
    1. What financial and operational considerations inform outsourcing 
facility operational and business model decisions?
    2. What factors impact the development of a sustainable outsourcing 
facility business?
    3. What financial and operational considerations inform outsourcing 
facility product decisions?
    4. Do outsourcing facilities understand the Federal legislative and 
regulatory policies that apply to them? What, if any, knowledge gaps 
need to be addressed?
    5. What challenges do outsourcing facilities face when implementing 
Federal current good manufacturing practice (CGMP) requirements?
    6. How do outsourcing facilities implement quality practices at 
their facilities?
    7. How is CGMP and quality expertise developed by outsourcing 
facilities? How do they obtain this knowledge, and what training do 
they need?
    8. What are the economic consequences of CGMP noncompliance/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 June 18, 2020 (85 FR 36857), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received four comments. Although four 
comments were received, three were not responsive to the four 
collection of information topics solicited and, therefore, will not be 
discussed in this document. The other comment included a number of 
suggested questions to expand upon the questions posed in the 60-day 
notice and, therefore, can be considered ways to enhance the quality, 
utility, and clarity of the information to be collected. While the 
questions will not be included verbatim in our survey instrument, FDA 
will give the questions due consideration as the Agency proceeds with 
this study.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveys, focus groups, and interviews..............................             300                2              600                1              600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 75330]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26066 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P

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