82 FR 56615 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 228 (November 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 228 (November 29, 2017)
| Page Range | 56615-56617 | |
| FR Document | 2017-25767 |
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)] [Notices] [Pages 56615-56617] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25767] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0505] 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. ----------------------------------------------------------------------- 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 December 29, 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 0910-0623. 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. 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 Sec. Sec. 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 [[Page 56616]] from cattle. FDA 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 (the 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, FDA is authorized to issue regulations for the FD&C Act's efficient enforcement. With regard to records concerning imported human food and cosmetics, FDA relied on its 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 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 Sec. Sec. 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 contains 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 FDA does not easily have access to records maintained at foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and 700.27(c)(6), respectively, require that when filing for entry with U.S. Customs and Border Protection (CBP), 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 containing-cattle material and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of Sec. Sec. 189.5 or 700.27. In addition, if human food or cosmetics were manufactured from, processed with, or otherwise containing-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, FDA may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials, and their use does not render human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be designated must send a written request to the Director of the Center for Food Safety and Applied Nutrition (CFSAN Director). The information the country is required to submit includes information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether SRMs, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, or MS beef from the country seeking designation should be considered prohibited cattle materials. FDA uses the information to determine whether to grant a request for designation and to impose conditions if a request is granted. Sections 189.5 and 700.27 further state that countries designated under Sec. Sec. 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether their designations remain appropriate. As part of this process, FDA may ask designated countries to confirm their BSE situation and that the information submitted by them, in support of their original application, has remained unchanged. FDA may revoke a country's designation if FDA determines that it is no longer appropriate. Therefore, designated countries may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. FDA uses the information to ensure their designations remain appropriate. Description of Respondents: Respondents to this information collection include manufacturers, processors, and importers of FDA regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle, as well as, with regard to Sec. Sec. 189.5(e) and 700.27(e), foreign governments seeking designation under those regulations. In the Federal Register of June 15, 2017 (82 FR 27501), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received three comments. One comment was unrelated to the information collection; one comment noted that the length of time to keep records was insufficient but offered no suggested timeframe; and one comment supported the information collection. After evaluating these comments FDA will not revise the information collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 189.5(c)(6) and 700.27(c)(6)................ 54,825 1 54,825 0.033 (2 minutes)......................... 1,809 189.5(e) and 700.27(e); request for 1 1 1 80........................................ 80 designation. [[Page 56617]] 189.5(e) and 700.27(e); response to request 1 1 1 26........................................ 26 for review by FDA. ------------------------------------------------ --------------- Total................................... .............. .............. .............. .......................................... 1,915 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Activity Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Domestic facilities......................... 697 52 36,244 0.25 (15 minutes)......................... 9,061 Foreign facilities.......................... 916 52 47,632 0.25 (15 minutes)......................... 11,908 ------------------------------------------------ --------------- Total................................... .............. .............. .............. .......................................... 20,969 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Except where otherwise noted, this estimate is based on FDA's estimate of the number of facilities affected by the final rule entitled ``Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle'' published in the Federal Register of October 11, 2006 (71 FR 59653). Reporting: FDA's regulations in Sec. Sec. 189.5(c)(6) and 700.27(c)(6) impose a reporting burden on importers of human food and cosmetics manufactured from, processed with, or otherwise containing cattle material. Importers of these products must affirm that the human food or cosmetics are not manufactured from, processed with, or otherwise contain prohibited cattle materials and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of Sec. Sec. 189.5 or 700.27. The affirmation is made by the importer of record at CBP entry. Affirmation by importers is expected to take approximately 2 minutes per entry line. Table 1 shows 54,825 lines of human food and cosmetics likely to contain cattle materials are imported annually. The reporting burden of affirming whether import entry lines contain cattle-derived materials is estimated to take 1,809 hours annually (54,825 lines x 2 minutes per line). FDA's estimate of the reporting burden for designation under Sec. Sec. 189.5 and 700.27 is based on its experience and the average number of requests for designation received in the past 3 years. In the last 3 years, FDA has not received any requests for designation. Thus, FDA estimates that one or fewer will be received annually in the future. Based on this experience, FDA estimates the annual number of new requests for designation will be one. FDA estimates that preparing the information required by Sec. Sec. 189.5 and 700.27 and submitting it to FDA in the form of a written request to the CFSAN Director will require a burden of approximately 80 hours per request. Thus, the burden for new requests for designation is estimated to be 80 hours annually, as shown in table 1, row 2. Under Sec. Sec. 189.5(e) and 700.27(e), designated countries are subject to future review by FDA and may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. In the last 3 years, FDA has not requested any reviews. Thus, FDA estimates that one or fewer will occur annually in the future. FDA estimates that the designated country undergoing a review in the future will need one-third of the time it took preparing its request for designation to respond to FDA's request for review, or 26 hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden for reviews is estimated to be 26 hours, as shown in table 1, row 3. The total reporting burden for this information collection is estimated to be 1,915 hours annually. Recordkeeping: FDA estimates that there are 697 domestic facility relationships and 916 foreign facility relationships consisting of the following facilities: An input supplier of cattle-derived materials that requires records (the upstream facility) and a purchaser of cattle-derived materials requiring documentation (this may be a human food or cosmetics manufacturer or processor). The recordkeeping burden of FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) is the burden of sending, verifying, and storing documents regarding shipments of cattle material that is to be used in human food and cosmetics. In this estimate of the recordkeeping burden, FDA treats these recordkeeping activities as shared activities between the upstream and downstream facilities. It is in the best interests of both facilities in the relationship to share the burden necessary to comply with the regulations; therefore, FDA estimates the time burden of developing these records as a joint task between the two facilities. Thus, FDA estimates that this recordkeeping burden will be about 15 minutes per week, or 13 hours per year, and FDA assumes that the recordkeeping burden will be shared between two entities (i.e., the ingredient supplier and the manufacturer of finished products). Therefore, the total recordkeeping burden for domestic facilities is estimated to be 9,061 hours (13 hours x 697), and the total recordkeeping burden for foreign facilities is estimated to be 11,908 hours (13 hours x 916), as shown in table 2. Dated: November 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25767 Filed 11-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56615
Reduced may be stored at ¥18 °C or This determination of the regulatory ACTION: Notice.
colder for up to 1 year after collection. review period establishes the maximum
• Preparation of Plasma Frozen potential length of a patent extension. SUMMARY: The Food and Drug
within 24 hours after Phlebotomy However, the USPTO applies several Administration (FDA) is announcing
(PF24), Leukocytes Reduced prepared statutory limitations in its calculations that a proposed collection of
from a whole blood collection. The of the actual period for patent extension. information has been submitted to the
product can be held at room In its application for patent extension, Office of Management and Budget
temperature up to 8 hours after this applicant seeks 894 days of patent (OMB) for review and clearance under
collection, refrigerated at 1 to 6 °C until term extension. the Paperwork Reduction Act of 1995.
separated, and placed at ¥18 °C or III. Petitions
DATES: Fax written comments on the
below within 24 hours of whole blood collection of information by December
collection. PF24, Leukocytes Reduced Anyone with knowledge that any of 29, 2017.
may be stored at ¥18 °C or colder for the dates as published are incorrect may ADDRESSES: To ensure that comments on
up to 1 year after collection. submit either electronic or written the information collection are received,
Subsequent to this approval, the comments and, under 21 CFR 60.24, ask OMB recommends that written
USPTO received a patent term for a redetermination (see DATES). comments be faxed to the Office of
restoration application for SOLX Furthermore, as specified in § 60.30 (21 Information and Regulatory Affairs,
SYSTEM (U.S. Patent No. 6,150,085) CFR 60.30), any interested person may OMB, Attn: FDA Desk Officer, Fax: 202–
from Haemonetics Corporation, and the petition FDA for a determination 395–7285, or emailed to oira_
USPTO requested FDA’s assistance in regarding whether the applicant for submission@omb.eop.gov. All
determining this patent’s eligibility for extension acted with due diligence comments should be identified with the
patent term restoration. In a letter dated during the regulatory review period. To OMB control number 0910–0623. Also,
November 5, 2015, FDA advised the meet its burden, the petition must include the FDA docket number found
USPTO that this human drug product comply with all the requirements of in brackets in the heading of this
had undergone a regulatory review § 60.30, including but not limited to: document.
period and that the approval of SOLX Must be timely (see DATES), must be
FOR FURTHER INFORMATION CONTACT: Ila
SYSTEM represented the first permitted filed in accordance with § 10.20, must
S. Mizrachi, Office of Operations, Food
commercial marketing or use of the contain sufficient facts to merit an FDA
and Drug Administration, Three White
product. Thereafter, the USPTO investigation, and must certify that a
Flint North, 10A–12M, 11601
requested that FDA determine the true and complete copy of the petition
Landsdown St., North Bethesda, MD
product’s regulatory review period. has been served upon the patent
20852, 301–796–7726, PRAStaff@
applicant. (See H. Rept. 857, part 1, 98th
II. Determination of Regulatory Review fda.hhs.gov.
Cong., 2d sess., pp. 41–42, 1984.)
Period Petitions should be in the format SUPPLEMENTARY INFORMATION: In
FDA has determined that the specified in 21 CFR 10.30. compliance with 44 U.S.C. 3507, FDA
applicable regulatory review period for Submit petitions electronically to has submitted the following proposed
SOLX SYSTEM is 1,250 days. Of this https://www.regulations.gov at Docket collection of information to OMB for
time, 708 days occurred during the No. FDA–2013–S–0610. Submit written review and clearance.
testing phase of the regulatory review petitions (two copies are required) to the Recordkeeping and Reporting
period, while 542 days occurred during Dockets Management Staff (HFA–305), Requirements for Human Food and
the approval phase. These periods of Food and Drug Administration, 5630 Cosmetics Manufactured From,
time were derived from the following Fishers Lane, Rm. 1061, Rockville, MD Processed With, or Otherwise
dates: 20852. Containing Material From Cattle—21
1. The date an exemption under Dated: November 24, 2017. CFR 189.5 and 700.27
section 505(i) of the Federal Food, Drug, Leslie Kux,
and Cosmetic Act (the FD&C Act) (21 OMB Control Number 0910–0623—
Associate Commissioner for Policy.
U.S.C. 355(i)) became effective: Extension
[FR Doc. 2017–25773 Filed 11–28–17; 8:45 am]
November 24, 2009. The applicant FDA’s regulations in §§ 189.5 and
BILLING CODE 4164–01–P
claims November 25, 2009, as the date 700.27 (21 CFR 189.5 and 700.27) set
the investigational new drug application forth bovine spongiform
(IND) became effective. However, FDA DEPARTMENT OF HEALTH AND encephalopathy (BSE)-related
records indicate that the IND effective HUMAN SERVICES restrictions applicable to FDA-regulated
date was November 24, 2009, which was human food and cosmetics. The
30 days after FDA receipt of the IND. Food and Drug Administration regulations designate certain materials
2. The date the application was from cattle as ‘‘prohibited cattle
initially submitted with respect to the [Docket No. FDA–2009–N–0505] materials,’’ including specified risk
human drug product under section materials (SRMs), the small intestine of
Agency Information Collection
505(b) of the FD&C Act: November 1, cattle not otherwise excluded from
Activities; Submission for Office of
2011. FDA has verified the applicant’s being a prohibited cattle material,
Management and Budget Review;
claim that the new drug application material from nonambulatory disabled
Comment Request; Recordkeeping
pmangrum on DSK3GDR082PROD with NOTICES1
(NDA) for SOLX SYSTEM (NDA cattle, and mechanically separated (MS)
and Reporting Requirements for
BN110059) was initially submitted on beef. Sections 189.5(c) and 700.27(c) set
Human Food and Cosmetics
November 1, 2011. forth the requirements for recordkeeping
Manufactured From, Processed With,
3. The date the application was or Otherwise Containing Material From and records access for FDA-regulated
approved: April 25, 2013. FDA has Cattle human food, including dietary
verified the applicant’s claim that NDA supplements, and cosmetics
BN110059 was approved on April 25, AGENCY: Food and Drug Administration, manufactured from, processed with, or
2013. HHS. otherwise containing material derived
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![Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56617
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR section responses per Total hours
respondents responses per response
respondent
189.5(e) and 700.27(e); response to request for re- 1 1 1 26 .............................. 26
view by FDA.
Total .................................................................. ........................ ........................ ........................ .................................... 1,915
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
Number of Total annual Average burden
Activity records per Total hours
recordkeepers records per recordkeeper
recordkeeper
Domestic facilities .................................................... 697 52 36,244 0.25 (15 minutes) ...... 9,061
Foreign facilities ....................................................... 916 52 47,632 0.25 (15 minutes) ...... 11,908
Total .................................................................. ........................ ........................ ........................ .................................... 20,969
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this on this experience, FDA estimates the 700.27(c) is the burden of sending,
estimate is based on FDA’s estimate of annual number of new requests for verifying, and storing documents
the number of facilities affected by the designation will be one. FDA estimates regarding shipments of cattle material
final rule entitled ‘‘Recordkeeping that preparing the information required that is to be used in human food and
Requirements for Human Food and by §§ 189.5 and 700.27 and submitting cosmetics.
Cosmetics Manufactured From, it to FDA in the form of a written
In this estimate of the recordkeeping
Processed With, or Otherwise request to the CFSAN Director will
Containing Material From Cattle’’ require a burden of approximately 80 burden, FDA treats these recordkeeping
published in the Federal Register of hours per request. Thus, the burden for activities as shared activities between
October 11, 2006 (71 FR 59653). new requests for designation is the upstream and downstream facilities.
Reporting: FDA’s regulations in estimated to be 80 hours annually, as It is in the best interests of both facilities
§§ 189.5(c)(6) and 700.27(c)(6) impose a shown in table 1, row 2. in the relationship to share the burden
reporting burden on importers of human Under §§ 189.5(e) and 700.27(e), necessary to comply with the
food and cosmetics manufactured from, designated countries are subject to regulations; therefore, FDA estimates
processed with, or otherwise containing future review by FDA and may respond the time burden of developing these
cattle material. Importers of these to periodic FDA requests by submitting records as a joint task between the two
products must affirm that the human information to confirm their facilities. Thus, FDA estimates that this
food or cosmetics are not manufactured designations remain appropriate. In the recordkeeping burden will be about 15
from, processed with, or otherwise last 3 years, FDA has not requested any minutes per week, or 13 hours per year,
contain prohibited cattle materials and reviews. Thus, FDA estimates that one and FDA assumes that the
must affirm that the human food or or fewer will occur annually in the recordkeeping burden will be shared
cosmetics were manufactured in future. FDA estimates that the between two entities (i.e., the ingredient
accordance with the applicable designated country undergoing a review supplier and the manufacturer of
requirements of §§ 189.5 or 700.27. The in the future will need one-third of the finished products). Therefore, the total
affirmation is made by the importer of time it took preparing its request for
recordkeeping burden for domestic
record at CBP entry. Affirmation by designation to respond to FDA’s request
facilities is estimated to be 9,061 hours
importers is expected to take for review, or 26 hours (80 hours × 0.33
approximately 2 minutes per entry line. = 26.4 hours, rounded to 26). The (13 hours × 697), and the total
Table 1 shows 54,825 lines of human annual burden for reviews is estimated recordkeeping burden for foreign
food and cosmetics likely to contain to be 26 hours, as shown in table 1, row facilities is estimated to be 11,908 hours
cattle materials are imported annually. 3. The total reporting burden for this (13 hours × 916), as shown in table 2.
The reporting burden of affirming information collection is estimated to be Dated: November 24, 2017.
whether import entry lines contain 1,915 hours annually. Leslie Kux,
cattle-derived materials is estimated to Recordkeeping: FDA estimates that
Associate Commissioner for Policy.
take 1,809 hours annually (54,825 lines there are 697 domestic facility
[FR Doc. 2017–25767 Filed 11–28–17; 8:45 am]
× 2 minutes per line). relationships and 916 foreign facility
FDA’s estimate of the reporting relationships consisting of the following BILLING CODE 4164–01–P
pmangrum on DSK3GDR082PROD with NOTICES1
burden for designation under §§ 189.5 facilities: An input supplier of cattle-
and 700.27 is based on its experience derived materials that requires records
and the average number of requests for (the upstream facility) and a purchaser
designation received in the past 3 years. of cattle-derived materials requiring
In the last 3 years, FDA has not received documentation (this may be a human
any requests for designation. Thus, FDA food or cosmetics manufacturer or
estimates that one or fewer will be processor). The recordkeeping burden of
received annually in the future. Based FDA’s regulations in §§ 189.5(c) and
VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 9990 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/82_FR_56843/page/3.svg)
Document Created: 2017-11-29 01:26:46
Document Modified: 2017-11-29 01:26:46
| 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 December 29, 2017. | |
| 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] | |
| FR Citation | 82 FR 56615 |
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