80 FR 37622 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 126 (July 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 126 (July 1, 2015)
| Page Range | 37622-37625 | |
| FR Document | 2015-16129 |
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)] [Notices] [Pages 37622-37625] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16129] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0742] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 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 July 31, 2015. 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 0910-0045. 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution--21 CFR Part 207 OMB Control Number 0910-0045--Extension Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health Service Act (42 U.S.C. 262), and part 207 (21 CFR part 207). Fundamental to FDA's mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States. Comprehensive, accurate, and up to date information is critical to conducting these activities with efficiency and effectiveness. Under section 510 of the FD&C Act, FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution. To implement section 510 of the FD&C Act, FDA issued part 207. Under current Sec. 207.20, manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishment. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Owners or operators of establishments that distribute under their own label or trade name a drug product manufactured by a registered establishment are not required either to register or list. However, distributors may elect to submit drug listing information in lieu of the registered [[Page 37623]] establishment that manufactures the drug product. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. Under current Sec. 207.21, establishments, both domestic and foreign, must register with FDA within 5 days after beginning the manufacture of drugs or biologicals, or within 5 days after the submission of a drug application or biological license application. In addition, establishments must register annually. Changes in individual ownership, corporate or partnership structure, location, or drug handling activity must be submitted as amendments to registration under current Sec. 207.26 within 5 days of such changes. Under Sec. 207.20(b), private label distributors may request their own labeler code and elect to submit drug listing information to FDA. In such instances, at the time of submitting or updating drug listing information, private label distributors must certify to the registered establishment that manufactured, prepared, propagated, compounded, or processed (which includes, among other things, repackaging and relabeling) the listed drug that the drug listing submission was made. Establishments must, within 5 days of beginning the manufacture of drugs or biologicals, submit to FDA a listing for every drug or biological product in commercial distribution at that time. Private label distributors may elect to submit to FDA a listing of every drug product they place in commercial distribution. Registered establishments must submit to FDA drug product listing for those private label distributors who do not elect to submit listing information. Under Sec. 207.25, product listing information submitted to FDA by domestic and foreign manufacturers must, depending on the type of product being listed, include any new drug application number or biological establishment license number, copies of current labeling and a sampling of advertisements, a quantitative listing of the active ingredient for each drug or biological product not subject to an approved application or license, the national drug code (NDC) number, and any drug imprinting information. In addition to the product listing information required, FDA may also require, under Sec. 207.31, a copy of all advertisements and a quantitative listing of all ingredients for each listed drug or biological product not subject to an approved application or license; the basis for a determination, by the establishment, that a listed drug or biological product is not subject to marketing or licensing approval requirements; and a list of certain drugs or biological products containing a particular ingredient. FDA may also request, but not require, the submission of a qualitative listing of the inactive ingredients for all listed drugs or biological products, and a quantitative listing of the active ingredients for all listed drugs or biological products subject to an approved application or license. Under Sec. 207.30, establishments must update their product listing information every June and December or, at the discretion of the establishment, when any change occurs. These updates must include the following information: (1) A listing of all drug or biological products introduced for commercial distribution that have not been included in any previously submitted list; (2) all drug or biological products formerly listed for which commercial distribution has been discontinued; (3) all drug or biological products for which a notice of discontinuance was submitted and for which commercial distribution has been resumed; and (4) any material change in any information previously submitted. No update is required if no changes have occurred since the previously submitted list. Historically, drug establishment registration and drug listing information have been submitted in paper form using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors) (collectively referred to as FDA Forms). Changes in the FD&C Act resulting from enactment of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Before the enactment of FDAAA, section 510(p) of the FD&C Act expressly provided for electronic submission of drug establishment registration information upon a finding that electronic receipt was feasible, and section 510(j) of the FD&C Act provided that drug listing information be submitted in the form and manner prescribed by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C Act, now expressly, requires electronic drug listing in addition to drug establishment registration. In certain cases, if it is unreasonable to expect a person to submit registration and listing information electronically, FDA may grant a waiver from the electronic format requirement. In the Federal Register of June 1, 2009 (74 FR 26248), FDA announced the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing'' (the 2009 guidance). The document provides guidance to industry on the statutory requirement to submit electronically drug establishment registration and drug listing information. The guidance describes the types of information to include for purposes of drug establishment registration and drug listing and how to prepare and submit the information in an electronic format (Structured Product Labeling (SPL) files) that FDA can process, review, and archive. In addition to the information that previously was collected on the FDA Forms, the guidance addresses electronic submission of other required information as follows:For registered foreign drug establishments, the name, address, and telephone number of its U.S. agent (Sec. 207.40(c)); the name of each importer that is known to the establishment (the U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment's drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or the patient) (section 510(i)(1)(A) of the FD&C Act); and the name of each person who imports or offers for import (the name of each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States) (section 510(i)(1)(A) of the FD&C Act). FDA also recommends the voluntary submission of the following additional information, when applicable: To facilitate correspondence between foreign establishments and FDA, the email address for the U.S. agent, and the telephone number(s) and email address for the importer and person who imports or offers for import their drug; a site-specific Data Universal Numbering System number for each entity (e.g., the registrant, establishments, U.S. agent, importer); the NDC product code for the source drug that is repacked or relabeled; [[Page 37624]] distinctive characteristics of certain listed drugs, i.e., the flavor, the color, and image of the actual solid dosage form; and registrants may indicate that they view as confidential the registrant's business relationship with an establishment, or an inactive ingredient. In addition to this collection of information, there is an additional burden for the following activities: preparing a standard operating procedure (SOP) for the electronic submission of drug establishment registration and drug listing information; creating the SPL file, including accessing and reviewing the technical specifications and instructional documents provided by FDA (accessible at http://www.fda.gov/oc/datacouncil/spl.html); reviewing and selecting appropriate terms and codes used to create the SPL file (accessible at http://www.fda.gov/oc/datacouncil/spl.html); obtaining the digital certificate used with FDA's electronic submission gateway and uploading the SPL file for submission (accessible at http://www.fda.gov/esg/default.htm); and requests for waivers from the electronic submission process as described in the draft guidance. When FDA published the 2009 guidance on submitting establishment registration and drug listing information in electronic format, the Agency also amended its burden estimates for OMB control number 0910- 0045 to include the additional burden for the collection of information that had not been submitted using the FDA forms, and to create and upload the SPL file. The amended burden estimates included the one-time preparation of an SOP for creating and uploading the SPL file. Although most firms will already have prepared an SOP for the electronic submission of drug establishment registration and drug listing information, each year additional firms will need to create an SOP. As provided in Table 2, FDA estimates that approximately 1,000 firms will have to expend a one-time burden to prepare, review, and approve an SOP, and the Agency estimates that it will take 40 hours per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours. In the Federal Register of March 23, 2015 (80 FR 15214), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. The comment noted that under Sec. 207.20(a), manufacturers, repackers, and relabelers are required to register their establishment and submit a listing of every drug or biological product in commercial distribution. Under Sec. 207.20(b), owners or operators of establishments that distribute under their own label or trade name a drug product manufactured by a registered establishment are not required either to register or list but may elect to submit drug listing information in lieu of the registered establishment that manufactures the drug product. The comment said that although the burden of listing private label drugs rests on the manufacturer, the standard industry practice has been to submit two separate listings under different marketing categories. The comment said that these listings are submitted either by the private label distributor or by the manufacturer and ``in order for the necessary information to be provided to FDA (all Offices and Centers) both listings are necessary.'' The comment also recommended that all drug listings should include the marketing category of the drug. FDA Response: Under section 510 of the FD&C Act and part 207, contract manufacturers (registered establishments) are required to list their products with FDA under their own labeler code. To properly identify such a listing, contract manufacturers should list products manufactured for a private label distributor by using one of following marketing categories: (1) Approved Drug Product Manufactured Exclusively For Private Label Distributor; (2) OTC Monograph Drug Product Manufactured Exclusively For Private Label Distributor; (3) Unapproved Drug Product Manufactured Exclusively For Private Label Distributor. Contract manufacturers may also include the private label distributor's labeling with the listing submission. Additionally, Sec. 207.20(b) requires that the private label distributor have its product listed under its own labeler code (using whatever marketing category is appropriate to the finished product (e.g., NDA, OTC Monograph, Unapproved Drug)). The private label distributor may elect to do this on its own. If the private label distributor elects not to do this, then the responsibility for submitting the additional listing falls on the registered establishment (the contract manufacturer). In Tables 1 and 2, the information collection requirements of the drug establishment registration and drug listing requirements have been grouped according to the information collection areas of the requirements. Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- New registrations, including new labeler codes requests 1,400 2 2,800 4.5 12,600 Annual updates of registration information............. 10,000 1 10,000 4.5 45,000 New drug listings...................................... 1,567 7 11,000 4.5 49,500 New listings for private label distributor............. 146 10.06 1,469 4.5 6,611 June and December updates of all drug listing 5,300 20 106,000 4.5 477,000 information........................................... Waiver requests........................................ 1 1 1 1 1 ------------------------------------------------------------------------------------------------ Total.............................................. ................. .................. ................. .................. 590,712 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 37625]] Table 2--Estimated Annual Recordkeeping Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Activity resulting from Section 510(p) of the FD&C Act as Number of Number of records Total annual Average burden amended by FDAAA recordkeepers per recordkeeper records per recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- One-time preparation of SOP.............................. 1,000 1 1,000 40 40,000 SOP maintenance.......................................... 3,295 1 3,295 1 3,295 Total................................................ 43,295 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the collection of information. Dated: June 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16129 Filed 6-30-15; 8:45 am] BILLING CODE 4164-01-P
![37622 Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total Number Annual Num- Number of Re- Average Bur- Annual Burden
Instrument of Respond- ber of Re- sponses per den Hours per Hours
ents spondents Respondent Response
Site visit semi-structured interview—program staff and
community partner organization staff ............................... 180 90 1 1.25 113
Site visit group discussion—program participants ............... 84 42 1 1.25 53
Estimated Total Annual Burden Hours ......................... ........................ ........................ ........................ ........................ 178
In compliance with the requirements DEPARTMENT OF HEALTH AND Registration of Producers of Drugs and
of Section 3506(c)(2)(A) of the HUMAN SERVICES Listing of Drugs in Commercial
Paperwork Reduction Act of 1995, the Distribution—21 CFR Part 207
Administration for Children and Food and Drug Administration
OMB Control Number 0910–0045—
Families is soliciting public comment Extension
on the specific aspects of the [Docket No. FDA–2011–N–0742]
information collection described above. Requirements for drug establishment
Copies of the proposed collection of Agency Information Collection registration and drug listing are set forth
information can be obtained and Activities; Submission for Office of in section 510 of the Federal Food,
comments may be forwarded by writing Management and Budget Review; Drug, and Cosmetic Act (the FD&C Act)
to the Administration for Children and Comment Request; Registration of (21 U.S.C. 360), section 351 of the
Producers of Drugs and Listing of Public Health Service Act (42 U.S.C.
Families, Office of Planning, Research
Drugs in Commercial Distribution 262), and part 207 (21 CFR part 207).
and Evaluation, 370 L’Enfant
Fundamental to FDA’s mission to
Promenade SW., Washington, DC 20447, protect the public health is the
Attn: OPRE Reports Clearance Officer. AGENCY: Food and Drug Administration,
HHS. collection of this information, which is
Email address: OPREinfocollection@ used for important activities such as
acf.hhs.gov. All requests should be ACTION: Notice. postmarket surveillance for serious
identified by the title of the information adverse drug reactions, inspection of
collection. SUMMARY: The Food and Drug drug manufacturing and processing
The Department specifically requests Administration (FDA) is announcing facilities, and monitoring of drug
comments on (a) whether the proposed that a proposed collection of products imported into the United
collection of information is necessary information has been submitted to the States. Comprehensive, accurate, and up
for the proper performance of the Office of Management and Budget to date information is critical to
functions of the agency, including (OMB) for review and clearance under conducting these activities with
whether the information shall have the Paperwork Reduction Act of 1995. efficiency and effectiveness.
practical utility; (b) the accuracy of the DATES: Fax written comments on the Under section 510 of the FD&C Act,
agency’s estimate of the burden of the collection of information by July 31, FDA is authorized to establish a system
proposed collection of information; (c) for registration of producers of drugs
2015.
the quality, utility, and clarity of the and for listing of drugs in commercial
information to be collected; and (d) ADDRESSES: To ensure that comments on distribution. To implement section 510
the information collection are received, of the FD&C Act, FDA issued part 207.
ways to minimize the burden of the
OMB recommends that written Under current § 207.20, manufacturers,
collection of information on
comments be faxed to the Office of repackers, and relabelers that engage in
respondents, including through the use
Information and Regulatory Affairs, the manufacture, preparation,
of automated collection techniques or propagation, compounding, or
other forms of information technology. OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_ processing of human or veterinary drugs
Consideration will be given to and biological products, including bulk
comments and suggestions submitted submission@omb.eop.gov. All
comments should be identified with the drug substances and bulk drug
within 60 days of this publication. substances for prescription
OMB control number 0910–0045. Also
Karl Koerper, include the FDA docket number found compounding, and drug premixes as
in brackets in the heading of this well as finished dosage forms, whether
Reports Clearance Officer.
document. prescription or over-the-counter, are
[FR Doc. 2015–16073 Filed 6–30–15; 8:45 am]
required to register their establishment.
BILLING CODE 4184–01–P
FOR FURTHER INFORMATION CONTACT: FDA In addition, manufacturers, repackers,
PRA Staff, Office of Operations, Food and relabelers are required to submit a
and Drug Administration, 8455 listing of every drug or biological
Colesville Rd., COLE–14526, Silver product in commercial distribution.
Spring, MD 20993–0002, PRAStaff@ Owners or operators of establishments
tkelley on DSK3SPTVN1PROD with NOTICES
fda.hhs.gov. that distribute under their own label or
trade name a drug product
SUPPLEMENTARY INFORMATION: In manufactured by a registered
compliance with 44 U.S.C. 3507, FDA establishment are not required either to
has submitted the following proposed register or list. However, distributors
collection of information to OMB for may elect to submit drug listing
review and clearance. information in lieu of the registered
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![Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37625
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity resulting from Section 510(p) of Number of record- Number of records Total annual Average burden Total hours
the FD&C Act as amended by FDAAA keepers per recordkeeper records per recordkeeping
One-time preparation of SOP ................ 1,000 1 1,000 40 40,000
SOP maintenance .................................. 3,295 1 3,295 1 3,295
Total ................................................ 43,295
1 There are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: June 25, 2015. DATES: The Authorization is effective as Homeland Security that there is a
Leslie Kux, of May 12, 2015. domestic emergency, or a significant
Associate Commissioner for Policy. ADDRESSES: Submit written requests for potential for a domestic emergency,
[FR Doc. 2015–16129 Filed 6–30–15; 8:45 am] single copies of the EUA to the Office involving a heightened risk of attack
BILLING CODE 4164–01–P of Counterterrorism and Emerging with a biological, chemical, radiological,
Threats, Food and Drug Administration, or nuclear agent or agents; (2) a
10903 New Hampshire Ave., Bldg. 1, determination by the Secretary of
DEPARTMENT OF HEALTH AND Rm. 4338, Silver Spring, MD 20993– Defense that there is a military
HUMAN SERVICES 0002. Send one self-addressed adhesive emergency, or a significant potential for
label to assist that office in processing a military emergency, involving a
Food and Drug Administration your request or include a fax number to heightened risk to U.S. military forces of
which the Authorization may be sent. attack with a biological, chemical,
[Docket No. FDA–2015–N–2044] See the SUPPLEMENTARY INFORMATION radiological, or nuclear agent or agents;
section for electronic access to the (3) a determination by the Secretary of
Authorization of Emergency Use of an Authorization. HHS that there is a public health
In Vitro Diagnostic Device for emergency, or a significant potential for
FOR FURTHER INFORMATION CONTACT: a public health emergency, that affects,
Detection of Enterovirus D68;
Availability Carmen Maher, Acting Assistant or has a significant potential to affect,
Commissioner for Counterterrorism national security or the health and
AGENCY: Food and Drug Administration, Policy and Acting Director, Office of security of U.S. citizens living abroad,
HHS. Counterterrorism and Emerging Threats, and that involves a biological, chemical,
ACTION: Notice. Food and Drug Administration, 10903 radiological, or nuclear agent or agents,
New Hampshire Ave., Bldg. 1, Rm. or a disease or condition that may be
SUMMARY: The Food and Drug 4347, Silver Spring, MD 20993–0002, attributable to such agent or agents; or
Administration (FDA) is announcing the 301–796–8510. (4) the identification of a material threat
issuance of an Emergency Use SUPPLEMENTARY INFORMATION: by the Secretary of Homeland Security
Authorization (EUA) (the Authorization) under section 319F–2 of the Public
for in an vitro diagnostic device for I. Background
Health Service (PHS) Act (42 U.S.C.
detection of Enterovirus D68 (EV–D68) Section 564 of the FD&C Act (21 247d–6b) sufficient to affect national
strains detected in North America in U.S.C. 360bbb–3) as amended by the security or the health and security of
2014. FDA issued this Authorization Project BioShield Act of 2004 (Pub. L. U.S. citizens living abroad.
under the Federal Food, Drug, and 108–276) and the Pandemic and All- Once the Secretary of HHS has
Cosmetic Act (the FD&C Act), as Hazards Preparedness Reauthorization declared that circumstances exist
requested by the Centers for Disease Act of 2013 (Pub. L. 113–5) allows FDA justifying an authorization under
Control and Prevention (CDC). The to strengthen the public health section 564 of the FD&C Act, FDA may
Authorization contains, among other protections against biological, chemical, authorize the emergency use of a drug,
things, conditions on the emergency use nuclear, and radiological agents. Among device, or biological product if the
of the authorized in vitro diagnostic other things, section 564 of the FD&C Agency concludes that the statutory
device. The Authorization follows the Act allows FDA to authorize the use of criteria are satisfied. Under section
February 6, 2015, determination by the an unapproved medical product or an 564(h)(1) of the FD&C Act, FDA is
Department of Health and Human unapproved use of an approved medical required to publish in the Federal
Services (HHS) Secretary that there is a product in certain situations. With this Register a notice of each authorization,
significant potential for a public health EUA authority, FDA can help assure and each termination or revocation of an
emergency that has a significant that medical countermeasures may be authorization, and an explanation of the
potential to affect national security or used in emergencies to diagnose, treat, reasons for the action. Section 564 of the
the health and security of U.S. citizens or prevent serious or life-threatening FD&C Act permits FDA to authorize the
living abroad and that involves EV–D68. diseases or conditions caused by introduction into interstate commerce of
On the basis of such determination, the biological, chemical, nuclear, or a drug, device, or biological product
Secretary of HHS also declared on radiological agents when there are no intended for use when the Secretary of
February 6, 2015, that circumstances adequate, approved, and available HHS has declared that circumstances
exist justifying the authorization of alternatives. exist justifying the authorization of
tkelley on DSK3SPTVN1PROD with NOTICES
emergency use of in vitro diagnostic Section 564(b)(1) of the FD&C Act emergency use. Products appropriate for
devices for detection of EV–D68 subject provides that, before an EUA may be emergency use may include products
to the terms of any authorization issued issued, the Secretary of HHS must and uses that are not approved, cleared,
under the FD&C Act. The Authorization, declare that circumstances exist or licensed under sections 505, 510(k),
which includes an explanation of the justifying the authorization based on or 515 of the FD&C Act (21 U.S.C. 355,
reasons for issuance, is reprinted in this one of the following grounds: (1) A 360(k), and 360e) or section 351 of the
document. determination by the Secretary of PHS Act (42 U.S.C. 262).
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Document Created: 2015-12-15 13:19:06
Document Modified: 2015-12-15 13:19:06
| 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 July 31, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 37622 |
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