81 FR 50523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Electronic Drug Product Reporting of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 147 (August 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 147 (August 1, 2016)
| Page Range | 50523-50525 | |
| FR Document | 2016-18048 |
[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)] [Notices] [Pages 50523-50525] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18048] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1428] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Electronic Drug Product Reporting of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 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 31, 2016. 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 [email protected]. All comments should be identified with the title. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown Street, North Bethesda, MD 20852, [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. Guidance for Industry: Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability--OMB Control Number 0910-- (NEW) On November 27, 2013, the President signed the Drug Quality and Security Act (DQSA) into law (Pub. L. 113-54). [[Page 50524]] The DQSA added a new section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Under section 503B(b), a compounder can register as an outsourcing facility with FDA. 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 or abbreviated new drug applications. 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). In the Federal Register of November 24, 2014 (79 FR 69857), FDA announced the availability of a revised draft guidance for industry entitled ``Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under section 503B of the FD&C Act, and as described in the revised draft guidance, an outsourcing facility must, at the time of initial registration and twice each year, in June and December, submit to FDA a report identifying the drugs compounded by the facility during the previous six-month period. For each identified drug, the outsourcing facility must provide certain information, which is listed in section 503B(b)(2)(A)(ii) of the FD&C Act and in the revised draft guidance. Each facility that elects to register as an outsourcing facility must report the following information to FDA for each product that it compounds:The active ingredient and strength of active ingredient per unit; the source of the active ingredient (bulk or finished drug); the National Drug Code (NDC) number of the source drug or bulk active ingredient, if available; the dosage form and route of administration; the package description; the number of individual units produced; and the NDC number of the final product, if assigned. Compounded product information must be submitted to FDA electronically using the Structured Product Labeling (SPL) format and in accordance with section IV of the FDA guidance entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing,'' available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064994.htm. Under the revised draft guidance, outsourcing facilities may request a waiver from the SPL electronic submission process by submitting a written request to FDA explaining why the use of electronic means is not reasonable for the person requesting the waiver. In response to the November 24, 2014, Federal Register notice, FDA received three comments on the revised draft guidance. Comments that addressed the information collection provisions are identified and discussed here. One comment expressed concern about being unable to submit a product report within the required 30-day reporting period because of the extensive amount of time to create a product report, especially for facilities with large product portfolios. The comment suggested that FDA did not recognize that each outsourcing facility will have numerous SPL entries into the electronic reporting system to make up a product report. In consideration of the comment, we have increased our burden estimate as reflected in the tables 1 and 2. We have also explained in the guidance that there are ways to simplify the submission of product reporting information and reduce the number of responses and total burden of submitting product reporting information. Initially, the creation of product report submissions can be time consuming, but submissions can be saved, updated, and resubmitted for subsequent reporting periods instead of creating a new submission each time. In addition, multiple strengths of the same drug, package sizes, and source NDC numbers can be consolidated into a single product submission in SPL. Based on current data for outsourcing facilities, we estimate approximately 55 outsourcing facilities will submit to FDA an initial report identifying all drugs compounded in the facility in the previous 6 months. By our calculation, each product's SPL submission is considered a separate response and therefore each facility's product report will include multiple responses. Taking into account that a particular product that is compounded into different strengths from different sources of active ingredient can be reported in a single SPL response, we estimate that the number of products reported per facility will average 220 products per facility. This estimate is based on current data in product reports. Concerning the comment that each outsourcing facility will have numerous SPL entries, again we have revised our previous estimate to account for the fact that each product report will consist of multiple SPL responses per facility. We estimate that preparing and submitting this information electronically could take up to approximately 2 hours for each initial SPL response. We also estimate that approximately 55 outsourcing facilities will submit to FDA a report twice each year identifying all drugs compounded at the facility in the previous 6 months. As described previously, we estimate on average 220 SPL responses per facility. We estimate that preparing and submitting this information electronically will take approximately one half hour per response. At the same time, we have reduced the burden for semi-annual product submissions reasoning that outsourcing facilities can save each SPL response once initially created and submitted. For subsequent reports, an outsourcing facility may resubmit the same file(s) after changing only the following data elements to appropriate values for the reporting period (along with other data as appropriate): RootID and version number (both SPL metadata); effective date (to identify the reporting period); and the number of units produced. Furthermore, if a product was not compounded during a particular reporting period, no SPL response needs be sent for that product during that reporting period. Finally, we expect to receive no more than one waiver request from the electronic submission process for initial product reports and semi- annual reports, and estimate each request will take 1 hour to prepare and submit to FDA. Therefore, we estimate the burden of this collection of information as follows: [[Page 50525]] Table 1--Estimated Initial Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Information collection activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Submission of Initial Product 55 220 12,100 2 24,200 Report......................... Waiver Request From Electronic 1 1 1 1 1 Submission of Initial Product Report......................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 24,201 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the information collection. Table 2--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Information collection activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission for June Product Report............ 55 220 12,100 0.5 (30 minutes)........................ 6,050 Submission for December Product Report........ 55 220 12,100 0.5 (30 minutes)........................ 6,050 Waiver Request From Electronic Submission of 1 1 1 1....................................... 1 Product Reports. --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 12,101 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the information collection. Dated: July 26, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-18048 Filed 7-29-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices 50523
of them, or 3,300 (= 66% × 5,000) of the opportunities for tobacco retailers. information collection activities
low estimate, currently engage in These comments primarily relate more associated with the current guidance
retailing activities (Ref. 1) Two PRA to the content and method of a retailer document. FDA is supportive of training
related comments were received in training program rather than the programs that assist retailers in
response to the 60-day notice. proposed collection of information complying with the tobacco control
The two comments both identified associated with the current guidance laws.
additional training options that could be document. At the same time, one FDA estimates the burden of this
used to provide further educational comment was supportive of the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Develop training program .................................................... 273,900 1 273,900 16 4,382,400
Develop written policy against sales to minors and em-
ployee acknowledgement ................................................. 273,900 1 273,900 1 273,900
Develop internal compliance check program ...................... 273,900 1 273,900 8 2,191,200
Total .............................................................................. ........................ ........................ ........................ ........................ 6,847,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
Training program .......................................................... 273,900 4 1,095,600 .25 (15 minutes) .... 279,300
Written policy against sales to minors and employee 273,900 4 1,095,600 .10 (6 minutes) ...... 109,560
acknowledgement.
Internal compliance check program ............................. 273,900 2 547,800 .5 (30 minutes) ...... 279,300
Total ...................................................................... ........................ ........................ ........................ ............................... 668,160
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that the total burden DEPARTMENT OF HEALTH AND OMB recommends that written
for this collection will be 7,515,660 HUMAN SERVICES comments be faxed to the Office of
hours (6,847,500 reporting + 668,160 Information and Regulatory Affairs,
recordkeeping). Food and Drug Administration OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
Reference [Docket No. FDA–2013–N–1428] submission@omb.eop.gov. All
1. Burke, Don, ‘‘Trends & Insights in the Agency Information Collection comments should be identified with the
Nicotine Delivery Category.’’ Management Activities; Submission for Office of title. Also include the FDA docket
Science Associates, Inc. Presentation at Management and Budget Review; number found in brackets in the
NATO Show, April 23, 2015. Accessed June Comment Request; Guidance for heading of this document.
2015. Industry on Electronic Drug Product FOR FURTHER INFORMATION CONTACT: FDA
Dated: July 26, 2016. Reporting of Human Drug PRA Staff, Office of Operations, Food
Leslie Kux, Compounding Outsourcing Facilities and Drug Administration, Three White
Under Section 503B of the Federal Flint North, 10A63, 11601 Landsdown
Associate Commissioner for Policy. Street, North Bethesda, MD 20852,
Food, Drug, and Cosmetic Act
[FR Doc. 2016–18092 Filed 7–29–16; 8:45 am] PRAStaff@fda.hhs.gov.
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In
HHS. compliance with 44 U.S.C. 3507, FDA
ACTION: Notice. has submitted the following proposed
collection of information to OMB for
SUMMARY: The Food and Drug
review and clearance.
Administration (FDA) is announcing
that a proposed collection of Guidance for Industry: Electronic
information has been submitted to the Product Reporting for Human Drug
Office of Management and Budget Compounding Outsourcing Facilities
sradovich on DSK3GMQ082PROD with NOTICES
(OMB) for review and clearance under Under Section 503B of the Federal
the Paperwork Reduction Act of 1995. Food, Drug, and Cosmetic Act;
DATES: Fax written comments on the Availability—OMB Control Number
collection of information by August 31, 0910—(NEW)
2016. On November 27, 2013, the President
ADDRESSES: To ensure that comments on signed the Drug Quality and Security
the information collection are received, Act (DQSA) into law (Pub. L. 113–54).
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![Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices 50525
TABLE 1—ESTIMATED INITIAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Information collection activity responses per burden per Total hours
respondents responses
respondent response
Submission of Initial Product Report ................................... 55 220 12,100 2 24,200
Waiver Request From Electronic Submission of Initial
Product Report ................................................................. 1 1 1 1 1
Total .............................................................................. ........................ ........................ ........................ ........................ 24,201
1 There are no capital costs or operating and maintenance costs associated with the information collection.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Information collection activity responses per burden per Total hours
respondents responses
respondent response
Submission for June Product Report ........................... 55 220 12,100 0.5 (30 minutes) .... 6,050
Submission for December Product Report .................. 55 220 12,100 0.5 (30 minutes) .... 6,050
Waiver Request From Electronic Submission of Prod- 1 1 1 1 ............................ 1
uct Reports.
Total ...................................................................... ........................ ........................ ........................ ............................... 12,101
1 There are no capital costs or operating and maintenance costs associated with the information collection.
Dated: July 26, 2016. Rockville, MD 20857, 301–796–5957, these guidelines, FDA invited public
Jeremy Sharp, email: Jason.Lewis@fda.hhs.gov. comment on the potential impact of the
Deputy Commissioner for Policy, Planning, SUPPLEMENTARY INFORMATION: fees authorized by section 743 of the
Legislation, and Analysis. FD&C Act on small businesses (76 FR
[FR Doc. 2016–18048 Filed 7–29–16; 8:45 am] I. Background 45818, August 1, 2011). The comment
BILLING CODE 4164–01–P Section 107 of FSMA (Pub. L. 111– period for this request ended November
353) added section 743 to the FD&C Act 30, 2011. As stated in FDA’s September
(21 U.S.C. 379j–31) to provide FDA with 2011 ‘‘Guidance for Industry:
DEPARTMENT OF HEALTH AND the authority to assess and collect fees Implementation of the Fee Provisions of
HUMAN SERVICES from, in part: (1) The responsible party Section 107 of the FDA Food Safety
for each domestic facility and the U.S. Modernization Act,’’ (http://
Food and Drug Administration agent for each foreign facility subject to www.fda.gov/Food/
[Docket No. FDA–2016–N–0007] a reinspection, to cover reinspection- GuidanceRegulation/
related costs; (2) the responsible party GuidanceDocuments
Food Safety Modernization Act for a domestic facility and an importer RegulatoryInformation/FoodDefense/
Domestic and Foreign Facility who does not comply with a recall ucm274176.htm), because FDA
Reinspection, Recall, and Importer order, to cover food 1 recall activities recognizes that for small businesses the
Reinspection Fee Rates for Fiscal Year associated with such order; and (3) each full cost recovery of FDA reinspection
2017 importer subject to a reinspection to or recall oversight could impose severe
cover reinspection-related costs economic hardship, FDA intends to
AGENCY: Food and Drug Administration, (sections 743(a)(1)(A), (B), and (D) of the consider reducing certain fees for those
HHS. FD&C Act). Section 743 of the FD&C Act firms. FDA does not intend to issue
ACTION: Notice. directs FDA to establish fees for each of invoices for reinspection or recall order
these activities based on an estimate of fees until FDA publishes a guidance
SUMMARY: The Food and Drug document outlining the process through
100 percent of the costs of each activity
Administration (FDA) is announcing the which firms may request a reduction in
for each year (sections 743(b)(2)(A)(i),
fiscal year (FY) 2017 fee rates for certain fees.
(ii), and (iv)), and these fees must be
domestic and foreign facility In addition, as stated in the
made available solely to pay for the
reinspections, failures to comply with a September 2011 Guidance, FDA is in
costs of each activity for which the fee
recall order, and importer reinspections the process of considering various
was incurred (section 743(b)(3)). These
that are authorized by the Federal Food, issues associated with the assessment
fees are effective on October 1, 2016,
Drug, and Cosmetic Act (the FD&C Act), and collection of importer reinspection
and will remain in effect through
as amended by the FDA Food Safety fees. The fee rates set forth in this notice
September 30, 2017. Section
Modernization Act (FSMA). These fees will be used to determine any importer
743(b)(2)(B)(iii) of the FD&C Act directs
are effective on October 1, 2016, and
sradovich on DSK3GMQ082PROD with NOTICES
FDA to develop a proposed set of reinspection fees assessed in FY 2017.
will remain in effect through September
guidelines in consideration of the II. Estimating the Average Cost of a
30, 2017.
burden of fee amounts on small Supported Direct FDA Work Hour for
FOR FURTHER INFORMATION CONTACT: businesses. As a first step in developing
Jason Lewis, Office of Resource FY 2017
Management, Office of Regulatory 1 The term ‘‘food’’ for purposes of this document FDA is required to estimate 100
Affairs, Food and Drug Administration, has the same meaning as such term in section 201(f) percent of its costs for each activity in
12420 Parklawn Dr., Rm. 2046, of the FD&C Act (21 U.S.C. 321(f)). order to establish fee rates for FY 2017.
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Document Created: 2016-07-30 06:26:05
Document Modified: 2016-07-30 06:26:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by August 31, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown Street, North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 50523 |
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