82 FR 18652 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 75 (April 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 75 (April 20, 2017)
| Page Range | 18652-18654 | |
| FR Document | 2017-07965 |
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)] [Notices] [Pages 18652-18654] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07965] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1619] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 (PRA). DATES: Fax written comments on the collection of information by May 22, 2017. 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 OMB control number 0910-0606. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. 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. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111; OMB Control Number 0910-0606--Extension On October 25, 1994, the Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) of the FD&C Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after current good manufacturing practice (CGMP) regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. 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 conditions that do not meet current good manufacturing practice regulations.'' Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act. In the Federal Register of June 25, 2007 (72 FR 34752), (the June 25, 2007, final rule), FDA published a final rule that established, in part 111 (21 CFR part 111), the minimum CGMP necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Records are an indispensable component of CGMP. The records required by FDA's regulations in part 111 provide the foundation for the planning, control, and improvement processes that constitute a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to ensure the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. In addition, by establishing recordkeeping requirements, FDA can ensure that industry follows CGMP during manufacturing, packaging, labeling, or holding operations. The regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations. The recordkeeping requirements of the regulations include establishing written procedures and maintaining records pertaining to: (1) Personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints. Description of Respondents: Manufacturers, dietary supplement manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. The recordkeeping requirements of the regulations in part 111 are set forth in each subpart. In table 1, we list the annual burdens associated with recordkeeping, as described in the June 25, 2007, final rule. For some provisions listed in table 1, we did not estimate the number of records per recordkeeper because recordkeeping occasions consist of frequent brief entries of dates, temperatures, monitoring results, or documentation that specific actions were taken. Information might be recorded a few times a day, week, or month. When the records burden involves frequent brief entries, we entered 1 as the default for the number of records per recordkeeper. For example, many of the records listed under Sec. 111.35 in table 1, such as Sec. 111.35(b)(2) (documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment), involve many [[Page 18653]] short sporadic entries over the course of the year, varying across equipment and plants in the industry. We did not attempt to estimate the actual number of recordkeeping occasions for these provisions, but instead entered an estimate of the average number of hours per year. We entered the default value of 1 as the number of records per recordkeeper for these and similar provisions. For Sec. 111.35, the entry for number of records is 1 as a default representing a large number of brief recordkeeping occasions. In many rows of table 1, we list a burden under a single provision that covers the written procedures or records described in several provisions. For example, the burden of the batch production records listed in table 1 under Sec. 111.260 includes the burden for records listed under Sec. 111.255 because the batch production records must include those records. The number of records for batch production records (and other records kept on a batch basis in table 1) equals the annual number of batches. The estimated burden for records kept by batch includes both records kept for every batch and records kept for some but not all batches. We use the annual number of batches as the number of records that will not necessarily be kept for every batch, such as test results or material review and disposition records, because such records are part of records, if they are necessary, that will be kept for every batch. In the Federal Register of September 29, 2016 (81 FR 66967), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received comments from two commenters. (Comment 1) One commenter had concerns about whether the processes being used to assess the contents of supplements are genuine and accurate and how this is regulated; whether records regarding labeling indicate what is actually contained in a supplement; and whether these records will be available to the public. These comments appear to address PRA issues of practical utility and ways to enhance the quality, utility, and clarity of the information to be collected. (Response 1) In this collection of information, FDA is evaluating the burden of retaining records and making them available to regulatory officials, but not the burden for proactively submitting them to FDA. FDA reviews the records maintained while conducting an investigation (e.g., during a facility inspection and during the followup communication until a particular investigation is closed out). The investigation of a particular firm by FDA is exempt from the PRA and is not included as part of the burden estimate. The required elements of labeling are part of different regulations and do not apply to this collection of information. The commenter also discussed the safety of a particular product but CGMP regulations deal with establishing a quality product, not necessarily a safe product. Finally, the commenter discussed allowing the records maintained to be made public. These records are required to be maintained by the firm and are not proactively submitted to FDA, but they are required to be made available to FDA during inspections. If FDA obtains these records during the investigation of a firm, the public can submit a Freedom of Information Act request but the document they would typically receive would be redacted because the records are the property of the firm. (Comment 2) The second commenter stated that the labeling on dietary supplement products should be consistent and FDA regulated, the term ``healthy'' should be required to have a standard meaning, and ``healthy'' should not be allowed to be used unless it meets FDA requirements of the term. (Response 2) The recordkeeping for CGMPs has nothing to do with the required elements of food and dietary supplement labeling, which are covered under FDA's labeling regulations. FDA recently published, on May 27, 2016, a final rule for Nutrition (and Supplement) Facts Labels (81 FR 33741), and is currently reviewing new requirements for labeling your food ``healthy''. This information collection for CGMP addresses recordkeeping for specifications for a label and labeling operations. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 111.14, Records of personnel practices, 15,000 4 60,000 1........................................ 60,000 including documentation of training. 111.23, Records of physical plant sanitation 15,000 1 15,000 0.2 (12 minutes)......................... 3,000 practices, including pest control and water quality. 111.35, Records of equipment and utensils 400 1 400 12.5..................................... 5,000 calibration and sanitation practices. 111.95, Records of production and process 250 1 250 45....................................... 11,250 control systems. 111.140, Records that quality control 240 1,163 279,120 1........................................ 279,120 personnel must make and keep. 111.180, Records associated with components, 240 1,163 279,120 1........................................ 279,120 packaging, labels, and product received for packaging and labeling as a dietary supplement. 111.210, Requirements for what the master 240 1 240 2.5...................................... 600 manufacturing record must include. 111.260, Requirements for what the batch 145 1,408 204,160 1........................................ 204,160 record must include. 111.325, Records that quality control 120 1 120 15....................................... 1,800 personnel must make and keep for laboratory operations. 111.375, Records of the written procedures 260 1 260 2........................................ 520 established for manufacturing operations. 111.430, Records of the written procedures 50 1 50 12.6..................................... 630 for packaging and labeling operations. 111.475, Records of product distribution and 15,000 1 15,000 0.4 (24 minutes)......................... 6,000 procedures for holding and distributing operations. [[Page 18654]] 111.535, Records for returned dietary 110 4 440 13.5..................................... 5,940 supplements. 111.570, Records regarding product complaints 240 600 144,000 0.5 (30 minutes)......................... 72,000 ---------------------------------------------------------------------------------------------------------- Total.................................... .............. .............. .............. ......................................... 929,140 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The average burden per recordkeeping estimates in table 1 are based on those in the June 25, 2007, final rule, which were based on our institutional experience with other CGMP requirements and on data provided by Research Triangle Institute in the ``Survey of Manufacturing Practices in the Dietary Supplement Industry'' cited in that rule. The estimates in table 1 of the number of firms affected by each provision of part 111 are based on the percentage of manufacturers, packagers, labelers, holders, distributors, and warehousers that reported in the survey that they have not established written SOPs or do not maintain records that were later required by the June 25, 2007, final rule. Because we do not have survey results for general warehouses, we entered the approximate number of facilities in that category for those provisions covering general facilities. For the dietary supplement industry, the survey estimated that 1,460 firms would be covered by the final rule, including manufacturers, packagers, labelers, holders, distributors, and warehousers. The time estimates include the burden involved in documenting that certain requirements are performed and in recordkeeping. We used an estimated annual batch production of 1,408 batches per year to estimate the burden of requirements that are related to the number of batches produced annually, such as Sec. 111.260, ``What must the batch production record include?'' The estimate of 1,408 batches per year is near the midpoint of the number of annual batches reported by survey firms. The length of time that CGMP records must be maintained is set forth in Sec. 111.605. Table 1 reflects the estimated burdens for written procedures, record maintenance, periodically reviewing records to determine if they may be discarded, and for any associated documentation for that activity for records that are required under part 111. We have not included a separate estimate of burden for those sections that require maintaining records in accordance with Sec. 111.605, but have included those burdens under specific provisions for keeping records. For example, Sec. 111.255(a) requires that the batch production records be prepared every time a batch is manufactured, and Sec. 111.255(d) requires that batch production records be kept in accordance with Sec. 111.605. The estimated burdens for both Sec. 111.255(a) and (d) are included under Sec. 111.260, what the batch record must include. Dated: April 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-07965 Filed 4-19-17; 8:45 am] BILLING CODE 4164-01-P
![18652 Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
Leroy A. Richardson, Current Good Manufacturing Practice corrective action was effective. In
Chief, Information Collection Review Office, in Manufacturing, Packaging, Labeling, addition, by establishing recordkeeping
Office of Scientific Integrity, Office of the or Holding Operations for Dietary requirements, FDA can ensure that
Associate Director for Science, Office of the Supplements—21 CFR Part 111; OMB industry follows CGMP during
Director, Centers for Disease Control and Control Number 0910–0606—Extension manufacturing, packaging, labeling, or
Prevention. holding operations. The regulations in
[FR Doc. 2017–07963 Filed 4–19–17; 8:45 am]
On October 25, 1994, the Dietary
Supplement Health and Education Act part 111 establish the minimum
BILLING CODE 4163–18–P
(DSHEA) (Pub. L. 103–417) was signed manufacturing practices necessary to
into law. DSHEA, among other things, ensure that dietary supplements are
amended the Federal Food, Drug, and manufactured, packaged, labeled, or
DEPARTMENT OF HEALTH AND held in a manner that will ensure the
HUMAN SERVICES Cosmetic Act (the FD&C Act) by adding
section 402(g) of the FD&C Act (21 quality of the dietary supplements
U.S.C. 342(g)). Section 402(g)(2) of the during manufacturing, packaging,
Food and Drug Administration labeling or holding operations.
FD&C Act provides, in part, that the
The recordkeeping requirements of
[Docket No. FDA–2013–N–1619] Secretary of Health and Human Services
the regulations include establishing
may, by regulation, prescribe good
written procedures and maintaining
Agency Information Collection manufacturing practices for dietary
records pertaining to: (1) Personnel; (2)
Activities; Submission for Office of supplements. Section 402(g) of the
sanitation; (3) calibration of instruments
Management and Budget Review; FD&C Act also stipulates that such
and controls; (4) calibration, inspection,
Comment Request; Current Good regulations will be modeled after or checks of automated, mechanical, or
Manufacturing Practice in current good manufacturing practice electronic equipment; (5) maintaining,
Manufacturing, Packaging, Labeling, or (CGMP) regulations for food and may cleaning, and sanitizing equipment and
Holding Operations for Dietary not impose standards for which there utensils and other contact surfaces; (6)
Supplements are no current, and generally available, water used that may become a
analytical methodology. Section component of the dietary supplement;
AGENCY: Food and Drug Administration, 402(g)(1) of the FD&C Act states that a (7) production and process controls; (8)
HHS. dietary supplement is adulterated if ‘‘it quality control; (9) components,
has been prepared, packed, or held packaging, labels and product received
ACTION: Notice.
under conditions that do not meet for packaging and labeling; (10) master
SUMMARY: The Food and Drug current good manufacturing practice manufacturing and batch production;
Administration (FDA) is announcing regulations.’’ Under section 701(a) of the (11) laboratory operations; (12)
that a proposed collection of FD&C Act (21 U.S.C. 371(a)), FDA may manufacturing operations; (13)
information has been submitted to the issue regulations necessary for the packaging and labeling operations; (14)
Office of Management and Budget efficient enforcement of the FD&C Act. holding and distributing operations; (15)
(OMB) for review and clearance under In the Federal Register of June 25, 2007 returned dietary supplements; and (16)
the Paperwork Reduction Act of 1995 (72 FR 34752), (the June 25, 2007, final product complaints.
(PRA). rule), FDA published a final rule that Description of Respondents:
established, in part 111 (21 CFR part Manufacturers, dietary supplement
DATES: Fax written comments on the 111), the minimum CGMP necessary for manufacturers, packagers and
collection of information by May 22, activities related to manufacturing, repackagers, labelers and re-labelers,
2017. packaging, labeling, or holding dietary holders, distributors, warehousers,
supplements to ensure the quality of the exporters, importers, large businesses,
ADDRESSES: To ensure that comments on dietary supplement. and small businesses engaged in the
the information collection are received, Records are an indispensable dietary supplement industry.
OMB recommends that written component of CGMP. The records The recordkeeping requirements of
comments be faxed to the Office of required by FDA’s regulations in part the regulations in part 111 are set forth
Information and Regulatory Affairs, 111 provide the foundation for the in each subpart. In table 1, we list the
OMB, Attn: FDA Desk Officer, FAX: planning, control, and improvement annual burdens associated with
202–395–7285, or emailed to oira_ processes that constitute a quality recordkeeping, as described in the June
submission@omb.eop.gov. All control system. Implementation of these 25, 2007, final rule. For some provisions
comments should be identified with the processes in a manufacturing operation listed in table 1, we did not estimate the
OMB control number 0910–0606. Also serves as the backbone to CGMP. The number of records per recordkeeper
include the FDA docket number found records show what is to be because recordkeeping occasions consist
in brackets in the heading of this manufactured; what was, in fact, of frequent brief entries of dates,
document. manufactured; and whether the controls temperatures, monitoring results, or
FOR FURTHER INFORMATION CONTACT:
that the manufacturer put in place to documentation that specific actions
JonnaLynn Capezzuto, Office of ensure the identity, purity, strength, and were taken. Information might be
Operations, Food and Drug composition and limits on contaminants recorded a few times a day, week, or
Administration, Three White Flint and to prevent adulteration were month. When the records burden
effective. Further, records will show involves frequent brief entries, we
asabaliauskas on DSK3SPTVN1PROD with NOTICES
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796– whether and what deviations from entered 1 as the default for the number
3794. control processes occurred, facilitate of records per recordkeeper. For
evaluation and corrective action example, many of the records listed
SUPPLEMENTARY INFORMATION: In concerning these deviations (including, under § 111.35 in table 1, such as
compliance with 44 U.S.C. 3507, FDA where necessary, whether associated § 111.35(b)(2) (documentation, in
has submitted the following proposed batches of product should be recalled individual equipment logs, of the date
collection of information to OMB for from the marketplace), and enable a of the use, maintenance, cleaning, and
review and clearance. manufacturer to assure that the sanitizing of equipment), involve many
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![18654 Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Total
Number of Average burden per Total
21 CFR section records per annual
recordkeepers recordkeeping hours
recordkeeper records
111.535, Records for returned dietary supplements ... 110 4 440 13.5 ........................ 5,940
111.570, Records regarding product complaints ........ 240 600 144,000 0.5 (30 minutes) ..... 72,000
Total ...................................................................... ........................ ........................ ........................ ................................ 929,140
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping included those burdens under specific site at: http://www.hrsa.gov/
estimates in table 1 are based on those provisions for keeping records. For vaccinecompensation/index.html.
in the June 25, 2007, final rule, which example, § 111.255(a) requires that the SUPPLEMENTARY INFORMATION: The
were based on our institutional batch production records be prepared program provides a system of no-fault
experience with other CGMP every time a batch is manufactured, and compensation for certain individuals
requirements and on data provided by § 111.255(d) requires that batch who have been injured by specified
Research Triangle Institute in the production records be kept in childhood vaccines. Subtitle 2 of Title
‘‘Survey of Manufacturing Practices in accordance with § 111.605. The XXI of the PHS Act, 42 U.S.C. 300aa–
the Dietary Supplement Industry’’ cited estimated burdens for both § 111.255(a) 10 et seq., provides that those seeking
in that rule. and (d) are included under § 111.260, compensation are to file a petition with
The estimates in table 1 of the number what the batch record must include. the U.S. Court of Federal Claims and to
of firms affected by each provision of Dated: April 14, 2017. serve a copy of the petition on the
part 111 are based on the percentage of Leslie Kux, Secretary of HHS, who is named as the
manufacturers, packagers, labelers, Associate Commissioner for Policy. respondent in each proceeding. The
holders, distributors, and warehousers [FR Doc. 2017–07965 Filed 4–19–17; 8:45 am] Secretary has delegated this
that reported in the survey that they responsibility under the program to
BILLING CODE 4164–01–P
have not established written SOPs or do HRSA. The Court is directed by statute
not maintain records that were later to appoint special masters who take
required by the June 25, 2007, final rule. DEPARTMENT OF HEALTH AND evidence, conduct hearings as
Because we do not have survey results HUMAN SERVICES appropriate, and make initial decisions
for general warehouses, we entered the as to eligibility for, and amount of,
approximate number of facilities in that Health Resources and Services compensation.
category for those provisions covering Administration A petition may be filed with respect
general facilities. For the dietary to injuries, disabilities, illnesses,
supplement industry, the survey National Vaccine Injury Compensation conditions, and deaths resulting from
estimated that 1,460 firms would be Program; List of Petitions Received vaccines described in the Vaccine Injury
covered by the final rule, including AGENCY: Health Resources and Services Table (the Table) set forth at 42 CFR
manufacturers, packagers, labelers, Administration (HRSA), Department of 100.3. This Table lists for each covered
holders, distributors, and warehousers. Health and Human Services (HHS). childhood vaccine the conditions that
The time estimates include the burden may lead to compensation and, for each
ACTION: Notice.
involved in documenting that certain condition, the time period for
requirements are performed and in SUMMARY: HRSA is publishing this occurrence of the first symptom or
recordkeeping. We used an estimated notice of petitions received under the manifestation of onset or of significant
annual batch production of 1,408 National Vaccine Injury Compensation aggravation after vaccine
batches per year to estimate the burden Program (the program), as required by administration. Compensation may also
of requirements that are related to the the Public Health Service (PHS) Act, as be awarded for conditions not listed in
number of batches produced annually, amended. While the Secretary of HHS is the Table and for conditions that are
such as § 111.260, ‘‘What must the batch named as the respondent in all manifested outside the time periods
production record include?’’ The proceedings brought by the filing of specified in the Table, but only if the
estimate of 1,408 batches per year is petitions for compensation under the petitioner shows that the condition was
near the midpoint of the number of program, the United States Court of caused by one of the listed vaccines.
annual batches reported by survey Federal Claims is charged by statute Section 2112(b)(2) of the PHS Act, 42
firms. with responsibility for considering and U.S.C. 300aa–12(b)(2), requires that
The length of time that CGMP records acting upon the petitions. ‘‘[w]ithin 30 days after the Secretary
must be maintained is set forth in FOR FURTHER INFORMATION CONTACT: For receives service of any petition filed
§ 111.605. Table 1 reflects the estimated information about requirements for under section 2111 the Secretary shall
burdens for written procedures, record filing petitions, and the program in publish notice of such petition in the
maintenance, periodically reviewing general, contact the Clerk, United States Federal Register.’’ Set forth below is a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
records to determine if they may be Court of Federal Claims, 717 Madison list of petitions received by HRSA on
discarded, and for any associated Place NW., Washington, DC 20005, March 1, 2017, through March 31, 2017.
documentation for that activity for (202) 357–6400. For information on This list provides the name of
records that are required under part 111. HRSA’s role in the program, contact the petitioner, city and state of vaccination
We have not included a separate Director, National Vaccine Injury (if unknown then city and state of
estimate of burden for those sections Compensation Program, 5600 Fishers person or attorney filing claim), and
that require maintaining records in Lane, Room 08N146B, Rockville, MD case number. In cases where the Court
accordance with § 111.605, but have 20857; (301) 443–6593, or visit our Web has redacted the name of a petitioner
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Document Created: 2017-04-20 01:42:20
Document Modified: 2017-04-20 01:42:20
| 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 May 22, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 18652 |
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